| | NICAS Ref | Published Ref | Title | Summary | Broadcast Date |
| Select | NICAS-971 | MDA-2020-014 | Pilling Clear Advantage aortic punch – risk of infection due to packaging failure | Manufactured by Teleflex – potential failure of packaging may lead to compromised sterility of device. | 20/04/2020 |
| Select | NICAS-957 | MDA-2020-004 | All lots of LemonPrep, PediaPrep Wave Prep and Cardio Prep - risk of contamination and transmission of infection | Manufactured by Mavidon – Products may be contaminated with the microorganism Burkholderia cepacia leading to an infection risk to patients. | 05/02/2020 |
| Select | NICAS-952 | MDA-2020-002 | Convex Two-Piece Skin Barriers for use with ostomy bags | Manufactured by ConvaTec – specific batches of convex two-piece skin barriers have been incorrectly manufactured with off-centre starter/stoma hole - recall due to risk of stoma injury, bleeding and leakage under the skin barrier | 16/01/2020 |
| Select | NICAS-948 | MDA-2019-046 | Arrow EZ-IO intraosseous vascular access needle sets – risk of needle stick injury | Manufactured by Teleflex (Arrow) All Lot and batch numbers – do not use needles if the safety cap is not in place as the risk of needle stick injury is increased and sterility of the needle may be compromised. | 23/12/2019 |
| Select | NICAS-949 | MDA-2019-045 | ApexPro telemetry server – risk of loss of alarms for ECG and pulse oximetry monitoring | Manufactured by GE – central monitoring station or bedside monitor may not provide visual or audible alarms for ECG arrythmias, lead failures or SpO2 monitoring when used with affected telemetry system. | 18/12/2019 |
| Select | NICAS-944 | MDA-2019-043 | Recall of Medicina IV Luer Slip syringe (IVS03) batch number 19040303 | Manufactured by Medicina – incorrectly packaged syringe with a needle could lead to a needlestick injury and loss of sterility due to needle breaching the packaging | 11/12/2019 |
| Select | NICAS-946 | MDA-2019-042 | Natus gold cup electrodes and snap electrode leads – risk of electric shock | Manufactured by Natus - GN Otometrics A/S – an exposed conductor may cause electric shock to user or patient. | 05/12/2019 |
| Select | NICAS-935 | MDA-2019-036 | Specific Hudson RCI Sheridan endotracheal tubes and connectors - 15 mm connector may detach from the tube before or during use | Manufactured by Teleflex Medical – disconnection can result in inadequate oxygenation and ventilation requiring medical intervention to avoid hypoxia, severe neurological injury or death. | 10/10/2019 |
| Select | NICAS-939 | MDA-2019-035 | Rocket and NuSurgix fetal blood sampling (FBS) amnioscopes and FBS kits – stop using ethyl chloride spray during the fetal blood sampling procedure with these devices | Manufactured by Rocket Medical and NuSurgix – potential incompatibility between ethyl chloride spray and the device. | 09/10/2019 |
| Select | NICAS-933 | MDA-2019-031 | Kiwi Complete Vacuum Delivery System – risk of failure to achieve or maintain vacuum during use (specific lot affected) | Manufactured by Clinical Innovations – if the device fails to generate or maintain a vacuum during the assisted delivery of a baby, additional intervention will be needed. | 30/09/2019 |
| Select | NICAS-930 | MDA-2019-029 | Deltec Gripper non-coring needles and PORT-A-CATH trays containing Gripper needles – recall due to risk of needle occlusion | Manufactured by Smiths Medical: due to a manufacturing process failure, needles may be occluded, potentially causing a delay to treatment. | 12/09/2019 |
| Select | NICAS-921 | MDA-2019-022 | Aisys & Aisys CS2 anaesthesia devices with Et Control option & software versions 11, 11SP01 & 11SP02 – risk of patient awareness due to inadequate anaesthesia | Manufactured by GE Healthcare – device may fail to deliver the set agent concentration in End Tidal Control mode. | 30/05/2019 |
| Select | NICAS-915 | MDA-2019-021 | Updated: Nellix Endovascular Aneurysm Sealing (EVAS) System - Device recall and enhanced patient surveillance | Endologix has stopped selling the Nellix EVAS device and is recalling unused stock. MHRA recommends enhanced patient surveillance due to a high risk of graft failure beyond two years after implantation.
Update includes further advice on how to detect features of Nellix endograft failures. This advice has been produced by MHRA’s Nellix independent Expert Advisory Group.
Note: This Medical Device Alert (MDA) updates guidance previously given in MDA-2019-002 issued 25 January 2019. | 02/05/2019 |
| Select | NICAS-919 | MDA-2019-020 | Hoists: Molift Mover 180/205 mobile hoist and Molift Air ceiling hoist - all sizes of 2-point sling bars – risk of fracture of hooks in use | Manufactured by Etac and supplied in UK by R82 UK Ltd – if the hooks connecting the spreader bar to the
hoist break during use, the patient could fall. | 01/05/2019 |
| Select | NICAS-914 | MDA-2019-016 | enFlow IV fluid & blood warmer - risk of unsafe levels of aluminium leaching from device – updated safety advice from manufacturer | Manufactured by Vyaire – Cartridges with an aluminium warming plate in the fluid pathway can lead to an IV infusion containing aluminium above currently recommended safe levels.
This MDA replaces MDA-2019-015. | 19/03/2019 |
| Select | NICAS-908 | MDA-2019-013 | All T34 ambulatory syringe pumps need a sponge pad fitted to the battery compartment to prevent battery connection issues | Manufactured by Caesarea Medical Electronics (CME) Ltd, a BD company – instructions provided to reduce the risk of delay to therapy and loss of infusion if the battery loses connection.
This MDA replaces MDA/2018/035. | 04/03/2019 |
| Select | NICAS-906 | MDA-2019-012 | Various ConvaTec devices - potentially breached sterile packaging | Manufactured by ConvaTec Limited - use of affected devices may increase risk of patients acquiring infections – extension to MDA/2018/034 as additional devices are affected.
Affected devices- rectal tubes, Unoversal drainage systems, SimpaVac, sterile suction connecting tubes, sterile connecting pieces, suction handles/sets (FilterFlow™/Deltaflo), oxygen catheters, sterile nasal oxygen cannulas, sterile oxygen connecting tubes, and sterile forceps | 28/02/2019 |
| Select | NICAS-907 | MDA-2019-011 | Multi parameter patient monitors: various Carescape, Dash & Solar monitors (see MDA) – risk of loss of patient monitoring | Manufactured by GE Healthcare - If networks are incorrectly configured with multiple monitors, a prolonged bandwidth overload condition may occur and cause monitors to restart | 27/02/2019 |
| Select | NICAS-905 | MDA-2019-010 | Professional use monitor/defibrillator: LIFEPAK 15 – risk of device failure during patient treatment and possible failure to deliver therapy | Manufactured by Stryker – potential for a lock-up condition where the device becomes non-responsive after a defibrillation shock has been delivered. Specific serial numbers are affected. | 20/02/2019 |
| Select | NICAS-902 | MDA-2019-007 | Ophthalmic implant Raindrop Near Vision Inlay – risk of corneal haze | Manufactured by ReVision Optics, Inc – patients implanted with this device have an increased risk of corneal haze. | 13/02/2019 |
| Select | NICAS-901 | MDA-2019-006 | Orthopaedic implant rHead Radial Head and Uni-Elbow: risk of early loosening | Manufactured by Stryker – post-operative loosening of the implant which may require revision surgery | 08/02/2019 |
| Select | NICAS-898 | MDA-2019-002 | Nellix Endovascular Aneurysm Sealing (EVAS) System - Device recall and enhanced patient surveillance | Endologix has stopped selling the Nellix EVAS device and is recalling unused stock. MHRA recommends enhanced patient surveillance due to a high risk of graft failure beyond two years after implantation. | 25/01/2019 |
| Select | NICAS-887 | MDA-2018-034 | Suction catheters, gastro-enteral tubes, intermittent urology catheters and sterile urine drainage bags – potential breach in sterile barrier packaging | Manufactured by ConvaTec Limited – use of affected devices may increase risk of patients getting infections. | 14/11/2018 |
| Select | NICAS-881 | MDA-2018-033 | CoaguChek Test Strips for Point of Care and Home Use – risk of false high results | Manufactured by Roche Diagnostics GmbH: affected CoaguChek test strips may give false high results for INR values above 4.5 when compared to laboratory results, this may lead to incorrect treatment decisions | 08/10/2018 |
| Select | NICAS-880 | MDA-2018-032 | Various trauma guide wires – risk of infection due to packaging failure | Manufactured by Zimmer Biomet with expiry dates prior to 31 May 2018 – wire may breach packaging, compromising sterility of device. | 24/09/2018 |
| Select | NICAS-876 | MDA-2018-029 | BenchMark Automated Slide Stainer series – FLO LOK III Reagent Dispenser Issue for IHC and ISH kits including INFORM HPV III Family 16 Probe (B) | Roche (Ventana Medical Systems) has released an expansion of products affected by the reagent dispenser issues causing weak staining and the potential for false negative results and misdiagnosis.
| 13/09/2018 |
| Select | NICAS-873 | MDA-2018-028 | Orthopaedic bone plates and cortical screws: ADVANSYS MLP-DLP; ADVANSYS TTC; Large QWIX; TIBIAXYS and UNI-CP–Sterile – Risk of infection | Manufactured by Newdeal SAS – Risk of infection from compromised packaging. | 01/08/2018 |
| Select | NICAS-870 | MDA-2018-026 | First generation JOURNEY BCS Knee System– Higher than expected risk of revision | Manufactured by Smith & Nephew – The device has a higher than expected risk of revision due to early component loosening. | 23/07/2018 |
| Select | NICAS-868 | MDA-2018-024R | All Alaris™ and Asena™ GS, GH, CC, TIVA, PK, enteral syringe pumps – risk of uncontrolled bolus of medicine. | Reissued - additional information has been added: Manufactured by CareFusion, now Becton Dickinson (BD) Medical – identify and replace the back-plate in the plunger assembly and note updated preventative maintenance schedule for these pumps. | 12/07/2018 |
| Select | NICAS-869 | MDA-2018-025R | Novaline haemodialysis bloodlines used with Baxter/Gambro haemodialysis machines – Recall of specific products due to various problems encountered during clinical use | Reissued - additional information has been added: Manufactured by Vital Healthcare Sdn, for distribution by Baxter Healthcare – all product codes manufactured in 2017. Various functional, assembly and clotting issues may lead to air entering the system, blood loss or delays in treatment. | 12/07/2018 |
| Select | NICAS-867 | MDA-2018-022R | SAM XT Extremity Tourniquet – Recall due to the risk of tourniquet failing in use updated | Manufactured by SAM Medical Products - An error in the manual sewing operations of devices manufactured from March 2017 to April 2018 may cause the seam holding the buckle to the belt to fail.
| 06/07/2018 |
| Select | NICAS-866 | MDA-2018-023 | Combur10 Test UX and Chemstrip 10 A test strips – risk of falsely low results when measuring test strips on the Urisys 1100 urine analyser. | Manufactured by Roche Diagnostics GmbH – Incorrect Limit of Detection (LoD) for protein, nitrite, ketone bodies, leukocytes, blood: intact erythrocytes, which may adversely impact patient treatment. | 05/07/2018 |
| Select | NICAS-864 | MDA-2018-021 | Alaris Smartsite Add-On Bag Access device – removal and destruction of specific batches due to risk of disconnection or leakage | Manufactured by BD (formerly Carefusion) – specific batches manufactured from July 2015 to Sept 2016 inclusive. Risk of leakage or disconnection of tubing caused by inadequately sealed connections. This may cause delay to infusion, under infusion, or exposure to hazardous infusates. | 21/06/2018 |
| Select | NICAS-863 | MDA-2018-020 | Smiths Medical CADD® Non Flow-Stop Medication Cassette Reservoirs – recall of specific lots due to risk of under delivery of medication | Smiths Medical CADD® Non Flow-Stop Medication Cassette Reservoirs may have been manufactured with an incorrect pressure plate which could cause partial or total occlusion of the tubing with no alarm. | 20/06/2018 |
| Select | NICAS-860 | MDA-2018-019 | JM103 and JM105 Jaundice Meters – risk of misinterpretation of out-of-range bilirubin measurements | Draeger Medical Systems – misinterpretation may cause delay of treatment of neonatal jaundice | 11/06/2018 |
| Select | NICAS-857 | MDA-2018-017 | Cook Vacuum Pump for IVF – risk of electric shock or burn to operator | Manufactured by Cook Medical – risk of electric shock or burn and failure of the device to operate due to non-compliant mains wiring during IVF procedures.
| 24/05/2018 |
| Select | NICAS-858 | MDA-2018-016 | Home use & Point of Care blood glucose monitoring system: Accu-Chek Aviva, Accu-Chek Performa & Accu-Chek Inform II test strips – risk of error messages and false high & low blood glucose results | Affected test strips, manufactured by Roche Diabetes Care, may give increased strip error messages prior to dosing with blood and in some cases may give false high or low readings, which may be hard to detect. | 18/05/2018 |
| Select | NICAS-853 | MDA-2018-014 | Infinity Acute Care System and M540 Patient Monitors software versions VG2.2-VG6.0 – risk that alarms are not activated | Manufactured by Draeger – a software issue may prevent the activation of audible and visual invasive blood pressure measurement alarms, risking a delay to treatment | 02/05/2018 |
| Select | NICAS-852 | MDA-2018-013 | cobas b 221 instruments with AutoQC module – software limitation affecting automatic QC measurements | Manufactured by Roche Diagnostics GmbH – Under specific circumstances scheduled automatic QC measurements may no longer be performed and erroneous patient results may remain undetected. | 01/05/2018 |
| Select | NICAS-851 | MDA-2018-012 | BD Vacutainer® EDTA & BD Vacutainer® Lithium Heparin Tubes – risk of incorrect results for lead testing or other assays using ASV methodology | Manufactured by Becton Dickinson (BD) – Due to a material in the rubber stopper, affected blood collection tubes may not be compatible with assays using Anodic Stripping Voltammetry (ASV) methodology. | 26/04/2018 |
| Select | NICAS-850 | MDA-2018-011 | Bone Cement: Optipac 40 Refobacin Revision and Optipac 80 Refobacin Revision – Risk of revision | Manufactured by Biomet – risk of revision surgery from an increase in bone cement polymerisation time and reduced mechanical strength. | 20/04/2018 |
| Select | NICAS-847 | MDA-2018-010 | All T34 ambulatory syringe pumps – risk of unintended pump shutdown and delay to treatment | Manufactured by Caesarea Medical Electronics (CME) Ltd – a variation in battery size can cause problems with connections in the battery housing. | 28/03/2018 |
| Select | NICAS-846 | MDA-2018-009 | Bag valve mask (BVM) manual resuscitation system – risk of damage to lungs by delivery of excessive pressure | Manufactured by Intersurgical – Valves may be incorrectly oriented, resulting in overpressure of the bag. | 02/03/2018 |
| Select | NICAS-842 | MDA-2018-005 | Roche Tissue Diagnostics – OptiView/Ultraview kits & Hematoxylin II - Dispenser failure of Hematoxylin II & Horseradish Peroxidase reagents | Roche Tissue Diagnostics (Ventana Medical Systems) – Leaking and sticking reagent dispensers may cause weak staining on tissue samples, which may lead to false negatives and misdiagnosis. | 15/02/2018 |
| Select | NICAS-844 | MDA-2018-007 | Zimmer Biomet, specific hip and trauma instruments: risk of infection | Manufactured by Zimmer GmbH – recall due to risk of infection as affected instruments may not be adequately cleaned when using standard cleaning instructions. | 15/02/2018 |
| Select | NICAS-841 | MDA-2018-004 | Recall - specific lots of RUSCH sensor (series 400) silicone & non-sterile rectal/pharyngeal temperature sensors | Manufactured by Teleflex – risk of misdiagnosis and delivery of inappropriate treatment as sensors may give an inaccurate temperature reading. | 14/02/2018 |
| Select | NICAS-840 | MDA-2018-003 | In vitro fertilisation (IVF) and assisted reproduction technologies (ART) products - precautionary measure | Manufactured by CooperSurgical: specific batches of products were manufactured with increased histamine levels in the gentamicin sulphate. | 22/01/2018 |
| Select | NICAS-834 | MDA-2017-037 | AlterG Anti-Gravity treadmill, model M320, used for rehabilitation after surgery – unexpected surge to maximum speed and failure of the emergency stop | Risk of injury to the patient if the treadmill suddenly goes to top speed. | 22/12/2017 |
| Select | NICAS-835 | MDA-2017-036 | Syringe pumps – required user actions in the event of PL3 alarm to prevent risk of interrupted infusion | BD Alaris/Asena syringe pumps (specific product codes) – internal malfunction may cause PL3 alarm to sound and the infusion to stop. | 20/12/2017 |
| Select | NICAS-836 | MDA-2017-035 | Nasogastric (NG) feeding tubes – recall due to risk of neonatal or paediatric patient choking on ENFIT connector cap | Manufactured by Maxter Catheters – patients could accidentally pull off the connector cap and choke on it.
| 19/12/2017 |
| Select | NICAS-832 | MDA-2017-034 | ThermoScientificTM OxoidTM CAZ10 ceftazidime, CT1629B antimicrobial susceptibility test disc – potential for false resistance results if stored at the wrong temperature | Manufactured by Oxoid Ltd (ThermoFisher Scientific) – antibiotic (ceftazidime) concentration may decrease over time if test disc is stored between 2°C and 8°C: only specific lots are affected. | 23/11/2017 |
| Select | NICAS-830 | MDA-2017-032 | Intra-aortic balloon pump (IABP): Maquet/Datascope CS100, CS100i and CS300 – potential for interruption or delay to therapy of critically ill patients | Manufactured by Maquet/Gettinge – a false blood detection alarm and/or fluid ingress could result in the failure of therapy to patients | 03/10/2017 |
| Select | NICAS-829 | MDA-2017-033 | Professional use HIV test: Alere HIV Combo – risk of false positive results | Manufactured by Alere – point-of-care tests for use ONLY in professional clinical settings: specific lots are affected | 03/10/2017 |
| Select | NICAS-828 | MDA-2017-031 | IntelliVue patient monitors used with 12-lead ECG – risk of ECG trace distortion Specific models and software versions affected. | Manufactured by Philips Healthcare: Error messages reporting a damaged or incorrectly functioning cable can trigger automatic corrective filtering of the ECG trace, distorting the ST segment, leading to risk of misinterpretation or misdiagnosis. | 28/09/2017 |
| Select | NICAS-827 | MDA-2017-030 | All Accu-Chek® Insight insulin pumps – risk of alarm failure | Manufactured by Roche Diabetes Care – the audible and/or vibration alarms might not function, which may lead to hyperglycaemia if the user doesn’t see the notification message on the pump. | 21/09/2017 |
| Select | NICAS-814 | MDA-2017-029 | Lung ventilators: Astral 100, 100SC and 150 – potential power loss due to faulty battery | Manufactured by ResMed – If operated only by the internal battery and this fails, the patient will not be ventilated. | 12/09/2017 |
| Select | NICAS-822 | MDA-2017-027 | Intra-Aortic Balloon Pump (IABP) – risk of hemodynamic instability to patients | Manufactured by Datascope Corp – an electrical fault caused by a solenoid valve could mean the device fails to start or deliver therapy to patients. | 25/08/2017 |
| Select | NICAS-823 | MDA-2017-025 | Nail intramedullary fixation system: Trauma guide wires 70cm – risk of infection | Manufactured by Zimmer Biomet – Recall due to risk of infection if the wire breaks through the packaging. | 24/08/2017 |
| Select | NICAS-817 | MDA-2017-026 | Overhead hoist: Freeway Easy Fit system with a swivelling trolley – risk of fixing pin moving or splaying | Manufactured by Prism – splayed or misplaced pins may lead to the hoop detaching and dropping the sling. | 24/08/2017 |
| Select | NICAS-818 | MDA-2017-024 | Novo Nordisk NovoPen Echo & NovoPen 5 – Risk of hyperglycaemia | Insulin pen manufactured by Novo Nordisk - Cartridge holder may be weakened and potentially break when exposed to certain household chemicals resulting in risk of hyperglycaemia. | 24/08/2017 |
| Select | NICAS-815 | MDA-2017-021 | BioMérieux VITEK 2 Identification (ID) /Antimicrobial Susceptibility Test (AST) Cards | Manufactured by BioMérieux – due to a manufacturing issue, some test card pouches might be damaged, resulting in antibiotic degradation. | 14/08/2017 |
| Select | NICAS-811 | MDA-2017-019 | Unomedical High Concentration Oxygen Masks - risk of hypoxia as tubing can disconnect from mask | Manufactured by ConvaTec – due to a manufacturing fault, the tubing may disconnect from the oxygen mask, prior to use or during use, causing a disruption in the supply of oxygen to patients. | 10/07/2017 |
| Select | NICAS-809 | MDA-2017-017 | BVM (Bag-Valve-Mask) Manual Resuscitation Systems – risk of delay to emergency treatment | Manufactured by Intersurgical – due to a manufacturing fault, the valve of the BVM System may become stuck during storage, leading to the intended tidal volume not being delivered and a delay to treatment. | 21/06/2017 |
| Select | NICAS-806 | MDA-2017-015 | Solus Laryngeal Mask Airway – risk of partial or total occlusion of the airway after inflating cuff | Manufactured by Intersurgical – due to a manufacturing fault, inflation of the cuff may reduce the airway tube cross-section, leading to partial or total occlusion of the airway and reduced air flow to and/or from a patient. | 09/06/2017 |
| Select | NICAS-802 | MDA-2017-012 | V60 Ventilator – Potential for unexpected shutdown. | Manufactured by Philips Respironics – Faulty software can cause false alarms for stalled blower motor, leading to unexpected shut down.
| 17/05/2017 |
| Select | NICAS-801 | MDA-2017-010 | All Accu-Chek® Insight insulin pumps – updated information for battery management. | Manufactured by Roche Diabetes Care - Replacement and update to MDA/2015/029 with new instructions to improve battery lifetime and prevent unexpected pump shut down or rapid battery depletion. | 02/05/2017 |
| Select | NICAS-799 | MDA-2017-008 | LMA Mucosal Atomization Device. | Manufactured by Teleflex - Poor atomisation of the spray could lead to inadequate topical anaesthesia delivery, leading to discomfort or difficulties delivering anaesthesia. | 24/04/2017 |
| Select | NICAS-797 | MDA-2017-009 | BD Plastipak Catheter tip Syringe with Luer slip adaptor, 100ml (all lots) | Product recall due to leakage past stopper which can result in under-dose or exposure of clinicians or patients to cytotoxic drugs. | 24/04/2017 |
| Select | NICAS-798 | MDA-2017-007 | LMA, MAD Nasal intranasal mucosal atomization device | Manufactured by Teleflex – failure of the device to deliver an atomised plume may impair the effectiveness of the medication, potentially resulting in serious injury or a life-threatening situation. | 21/04/2017 |
| Select | NICAS-794 | MDA-2017-004 | Cardiosave Hybrid Intra-aortic balloon pump (IABP) and Cardiosave Rescue IABP | CARDIOSAVE Hybrid intra-aortic balloon pump (IABP) and CARDIOSAVE Rescue IABP – damaged lithium ion batteries may give off smoke, a bad smell or produce sparks
| 07/03/2017 |
| Select | NICAS-792 | MDA-2017-003 | Alaris syringe pumps (except Alaris ‘System’ & IVAC PCAM) – risk of uncontrolled bolus of medicine. | Manufactured by CareFusion – Updates and replaces to MDA/2016/023 as the manufacturer has identified that the potential for unintended bolus of medication to occur when using any syringe type in syringe pumps that have a broken spring in the plunger assembly. | 20/02/2017 |
| Select | NICAS-791 | MDA-2017-002 | Reflection Dead Blow Mallet – risk of lead exposure | Manufactured by Smith & Nephew – cracking of the welds on the head of the mallet can result in lead beads and particles escaping and entering the surgical wound, potentially having effects associated with lead exposure | 17/02/2017 |
| Select | NICAS-790 | MDA-2017-001 | Oxylog 3000 and Oxylog 3000 plus ventilator – risk of ventilator failure | Manufactured by Dräger – Ventilator may stop working if a faulty control knob generates a potentiometer error. | 08/02/2017 |
| Select | NICAS-787 | MDA-2016-023 | Alaris Syringe Pumps – risk of uncontrolled siphonage with non-compatible syringes | Manufactured by Carefusion – use of non-recommended syringes in faulty Alaris Syringe Pumps may cause unintended siphonage of medication
| 22/12/2016 |
| Select | NICAS-785 | MDA-2016-022 | Heater-cooler devices used in cardiac surgery - risk of infection with Mycobacterium species. | Heater cooler Manufactures have updated advice on device management, for systems known or suspected to be contaminated with mycobacterium chimaera.
| 13/12/2016 |
| Select | NICAS-780 | MDA-2016-018 | Automatic external defibrillator (AED) LIFEPAK CR Plus and LIFEPAK EXPRESS – risk of failure to deli | Manufactured by Physio-Control – risk of delay to defibrillation due to an intermittent component failure. Specific serial numbers are affected. | 14/10/2016 |
| Select | NICAS-777 | MDA-2016-017 | AIRVO™2 and myAIRVO™2 humidifier – risk of undetected auditory alarm | Manufactured by Fisher & Paykel Healthcare Ltd – updated instructions for use to check the speaker before each use as undetected auditory alarms could result in the patient becoming hypoxic.
| 02/09/2016 |
| Select | NICAS-776 | MDA-2016-015 | Accu-Chek Insight insulin pump system manufactured by Roche Diabetes Care | Cartridges inserted incorrectly can leak insulin into the cartridge compartment, resulting in an under-delivery of insulin, which may lead to rapid deterioration of health, diabetic ketoacidosis or death. | 15/08/2016 |
| Select | NICAS-775 | MDA-2016-014 | Home use blood glucose monitoring system - TRUEresult and TRUEtrack blood glucose test strips | Manufactured by Nipro Diagnostics, certain lots of test strips may give incorrect low blood glucose results that could lead to undetected hyperglycaemia. This Alert refers to different blood glucose test strips to those covered by MDA/2016/009R. | 10/08/2016 |
| Select | NICAS-774 | MDA-2016-013 | SerenoCem Granules – risk of bone reabsorption around granules | Manufactured by Corinthian Surgical Ltd - risk of bone reabsorbtion around granules implanted in the middle ear. | 04/08/2016 |
| Select | NICAS-773 | MDA-2016-012 | VentStar Oxylog3000F (P) 190 Disposable paediatric ventilation circuit for Oxylog 3000 | Manufactured by Draeger Medical – Return ventilation circuits manufactured up to and including March 2016 as they may leak at the check valve.
| 03/08/2016 |
| Select | NICAS-772 | MDA-2016-011 | Babytherm Infant Warmer | In skin-temperature control mode, if the temperature sensor is not connected or detaches from the patient, the heating element may overheat causing particles to detach; potentially leading to fire and patient harm or death. | 02/08/2016 |
| Select | NICAS-771 | MDA-2016-010 | RightSign HIV 1.2.O Rapid Test Cassette, HCV Rapid Test Cassette & HBsAg Rapid | Manufactured by Hangzhou Biotest Biotech Co Ltd: certain lots of these devices may give false negative or false positive results when testing for HIV, HCV and HBV.
| 26/07/2016 |
| Select | NICAS-767 | MDA-2016-009R | Home use blood glucose monitoring system: TRUEyou blood glucose test strips | Manufactured by Nipro Diagnostics, certain lots of test strips may give incorrect low blood glucose results that could lead to undetected hyperglycaemia.
| 01/07/2016 |
| Select | NICAS-765 | MDA-2016-009 | Home use blood glucose monitoring system: TRUEyou blood glucose test strips | Manufactured by Nipro Diagnostics, certain lots of test strips may give incorrect low blood glucose results that could lead to undetected hyperglycaemia.
| 30/06/2016 |
| Select | NICAS-764 | MDA-2016-008 | Clinical chemistry tests: Siemens ADVIA Chemistry and Dimension/Dimension Vista products | Clinical chemistry tests: Siemens ADVIA Chemistry and Dimension/Dimension Vista products – risk of false low results due to interference with N-acetylcysteine (NAC).
| 22/06/2016 |
| Select | NICAS-763 | MDA-2016-007 | Bipolar QuickSite and QuickFlex lead models: 1056T, 1058T, 1156T and 1158T manufactured by St Jude | Bipolar QuickSite and QuickFlex lead models: 1056T, 1058T, 1156T and 1158T manufactured by St Jude Medical – risk of worsening heart failure symptoms due to wear and/or abrasion of lead insulation after implantation.
| 21/06/2016 |
| Select | NICAS-762 | MDA-2016-006 | CADD administration sets with Flow Stop free-flow protection | "CADD® administration sets with Flow Stop free-flow protection manufactured by Smiths Medical ASD – risk of under-infusion.
All devices with an expiration date on or before 31 March 2021 are at risk of under-infusing so we advise users to undertake a risk assessment before using them." | 24/05/2016 |
| Select | NICAS-761 | MDA-2016-005 | Accu-Check Insight insulin pump system - Risk of inappropriate treatment | "Accu-Chek® Insight insulin pump system,
manufactured by Roche Diabetes Care – Risk of a hypoglycaemic event if users misinterpret maintenance message ‘M-83 pump not able to complete task’. Users are advised to check pump history before re-initiating a programmed task (e.g. bolus delivery)." | 16/05/2016 |
| Select | NICAS-759 | MDA-2016-004 | Estradiol immunoassays – interference from the drug fulvestrant (Faslodex) may cause falsely elevate | "Estradiol immunoassays – interference from the drug fulvestrant (Faslodex®) may cause falsely elevated estradiol results.
Manufactured by Siemens Healthcare Diagnostics Inc. / Siemens Healthcare Diagnostics Ltd and Roche Diagnostics GmbH- assay interference from the drug fulvestrant (Faslodex®) may cause falsely elevated estradiol results." | 24/03/2016 |
| Select | NICAS-757 | MDA-2016-003 | All ZeniPower mercury-free hearing aid batteries – low risk of batteries exploding during use or if | "All ZeniPower mercury-free hearing aid batteries – low risk of batteries exploding during use or if depleted.
Manufactured by Zhuhai Zhi Li Battery Co Ltd – stop using batteries with certain best before dates." | 10/03/2016 |
| Select | NICAS-753 | MDA-2016-001 | Various nebulizers and nebulization kits – risk of nebulizer not delivering therapy to the patient. | Various nebulizers and nebulization kits – risk of nebulizer not delivering therapy to the patient. Manufactured by Unomedical Inc / Convatec Ltd – recall due to a manufacturing fault. | 26/01/2016 |
| Select | NICAS-752 | MDA-2015-039 | Home use blood glucose monitoring system - GlucoMen LX Sensor test strips – risk of over-estimation | "Home use blood glucose monitoring system - GlucoMen LX Sensor test strips – risk of over-estimation of blood glucose.
Distributed by Menarini Diagnostics UK – problem of possible over-estimation of blood glucose if test strips have been exposed to high humidity." | 21/12/2015 |
| Select | NICAS-747 | MDA-2015-037 | Sapphire multi-therapy and epidural pumps – update to instructions for use regarding fluctuations in | Sapphire multi-therapy and epidural pumps – update to instructions for use regarding fluctuations in flow rate accuracy in epidural mode. Manufactured by Q Core Medical, distributed in the UK by Hospira – potential over-infusion of epidural infusions. | 18/11/2015 |
| Select | NICAS-744 | MDA-2015-035 | Enteral syringe pumps P500, P700 and P900 – recall because CE marking is invalid. | Enteral syringe pumps P500, P700 and P900 – recall because CE marking is invalid. Manufactured by Medicina Ltd - the safety and performance of these devices has not been properly evaluated. | 29/09/2015 |
| Select | NICAS-742 | MDA-2015-033 | Sterile electrosurgical forceps and electrodes. Manufactured by Zethon Limited and Ross Electro Medi | Sterile electrosurgical forceps and electrodes. Manufactured by Zethon Limited and Ross Electro Medical Limited. Some devices may not be sterile – recall of specific batches. | 26/08/2015 |
| Select | NICAS-741 | MDA-2015-032 | Charging base for surgical hair clippers. Manufactured by Medline Industries | Charging base for surgical hair clippers. Manufactured by Medline Industries. Risk of fire in oxygen-rich environment if defective charging base overheats – recall of specific lots | 25/08/2015 |
| Select | NICAS-740 | MDA-2015-031 | Home-use blood glucose monitoring system | "Home-use blood glucose monitoring system: Accu-Chek? Mobile meter and Accu-Chek? Mobile test cassette – manufactured by Roche Diabetes.
This device may give falsely high readings if the specific testing procedure is not followed and, as a consequence, patients may take insulin when they don’t need it." | 18/08/2015 |
| Select | NICAS-739 | MDA-2015-030 | Shiley neonatal and paediatric tracheostomy tubes, manufactured by Medtronic (previously Covidien): | Shiley neonatal and paediatric tracheostomy tubes, manufactured by Medtronic (previously Covidien): specific product and lot numbers are affected. Shiley NEF/NCF/PEF/PCF/PELF/PLCF tracheostomy tubes are being recalled, as some patients experience breathing difficulties when changing to these earlier models of tube from current tubes. | 05/08/2015 |
| Select | NICAS-737 | MDA-2015-028 | Automatically retracting safety syringes, including insulin syringes, manufactured by Medicina Ltd. | Automatically retracting safety syringes, including insulin syringes, manufactured by Medicina Ltd. The manufacturer is recalling these devices due to two problems: there is a risk of needle stick injury as they may not automatically retract and the shelf life stated on the devices is incorrect, compromising the sterility of the product. | 04/08/2015 |
| Select | NICAS-738 | MDA-2015-029 | Accu-Chek Insight Insulin Pumps | Accu-Chek Insight Insulin Pumps - manufactured by Roche Diabetes Care. | 04/08/2015 |
| Select | NICAS-736 | MDA-2015-027 | Steel cannula infusion sets manufactured by Unomedical a/s | Steel cannula infusion sets manufactured by Unomedical a/s. Risk of the needle breaking in use, which may cause leakage of medication and require surgical intervention to remove the needle. | 23/07/2015 |
| Select | NICAS-732 | MDA-2015-023 | Kent and Ascot baths with a transfer seat and shepherd’s crook / shower pole fitted. Manufactured b | Transfer seat may detach from the bath, causing the occupant to fall and be seriously injured. | 22/06/2015 |
| Select | NICAS-729 | MDA-2015-021R | Philips ventilators: BiPAP autoSV, BiPAP autoSV Advanced, OmniLab Advanced, OmniLab Advanced + and | Philips ventilators: BiPAP autoSV, BiPAP autoSV Advanced, OmniLab Advanced, OmniLab Advanced + and HeartPAP devices. Increased risk of death for patients with a specific heart condition if being treated with Adaptive ServoVentilation (ASV) mode on ResMed ventilators. As a result, Philips recommend the same actions are taken while determining if this impacts their ventilators. | 22/05/2015 |
| Select | NICAS-728 | MDA-2015-021 | Philips ventilators - BiPAP autoSV/BiPAP autoSV Advanced devices | "Philips ventilators: BiPAP autoSV/BiPAP autoSV Advanced devices.
Increased risk of death for patients with a specific heart condition if being treated with Adaptive ServoVentilation (ASV) mode on ResMed ventilators. As a result, Philips recommend the same actions are taken while determining if this impacts their ventilators." | 21/05/2015 |
| Select | NICAS-727 | MDA-2015-020 | Specific ResMed ventilators with Adaptive ServoVentilation mode of ventilation | Specific ResMed ventilators with Adaptive ServoVentilation mode of ventilation. ResMed have identified a risk of increased cardiovascular death in patients who have a specific heart condition (see background) and are being treated with Adaptive ServoVentilation (ASV) mode on ResMed ventilators. | 13/05/2015 |
| Select | NICAS-726 | MDA-2015-019 | All Birdie mobile hoists (lifters) manufactured by Invacare | All Birdie mobile hoists (lifters) manufactured by Invacare. A change to the design of the carabiner used to hold the spreader bar in place and an update to the instructions for use. | 28/04/2015 |
| Select | NICAS-721 | MDA-2015-017 | Dental panoramic X-ray systems – CS 8100 and CS 8100 3D - Manufactured by Carestream Health between | "Dental panoramic X-ray systems – CS 8100 and CS 8100 3D. Manufactured by Carestream Health between June 2012 and September 2014.
Risk of injury to patient and/or user if the dental head unit drops down unexpectedly. The manufacturer will inspect all devices and replace any faulty parts it finds." | 10/04/2015 |
| Select | NICAS-720 | MDA-2015-016 | All Mackworth Healthcare Ltd slings fitted with a DOSEC clip. | All Mackworth Healthcare Ltd slings fitted with a DOSEC clip. The manufacturer has issued a ‘General User Safety Guide’ and updated its product specific user guides on risk assessments and the correct use of slings with DOSEC clips. | 02/04/2015 |
| Select | NICAS-719 | MDA-2015-015 | Hudson RCI© humidifier adaptors and Aquapak sterile water with humidifier adaptors. Manufactured by | Hudson RCI© humidifier adaptors and Aquapak sterile water with humidifier adaptors. Manufactured by Teleflex Medical. Specific product and lot numbers are affected. Risk of inhalation of foreign particles. The packaging may contain pieces of plastic which could get into the gas flow path and enter the lungs. | 01/04/2015 |
| Select | NICAS-718 | NIA-2015-003 | Interruption in supply of certain Baxter COLLEAGUE pump compatible IV administration sets | Interruption in supply of certain Baxter COLLEAGUE pump compatible IV administration sets. | 27/03/2015 |
| Select | NICAS-717 | MDA-2015-014 | V-Green spinal needle 25G pack. Product code 0181.052. Manufactured by Vygon. | "V-Green spinal needle 25G pack. Product code 0181.052. Manufactured by Vygon.
Risk of delay in treatment or repeat of procedure due to incorrect size of introducer needle supplied in the pack. Vygon is recalling a specific batch of this device." | 26/03/2015 |
| Select | NICAS-716 | MDA-2015-013 | Enteral feeding devices and accessories - various products - manufactured by Medicina Ltd | "Enteral feeding devices and accessories, syringes, plasters, dressings and rectal straws. Various product codes and specific batches. Manufactured by Medicina Ltd.
Enteral feeding devices and accessories.
The manufacturer is recalling these devices because the CE marking is invalid. In addition, there is a risk of infection from using the gastrostomy button feeding kits because they may contain out-of-date devices." | 23/03/2015 |
| Select | NICAS-715 | MDA-2015-012 | INRatio® and INRatio®2 PT/INR coagulation monitor and test strips used at home and at point of care. | INRatio® and INRatio®2 PT/INR coagulation monitor and test strips used at home and at point of care. Manufactured by Alere. In people with certain medical conditions these devices can give low blood coagulation results, which can lead to them taking the wrong dose of anticoagulation medicine. | 19/03/2015 |
| Select | NICAS-714 | MDA-2015-011 | Satella-X ceiling suspended skull x-ray unit. Manufactured by NRT. Distributed from 1980 to 2006 inc | Satella-X ceiling suspended skull x-ray unit. Manufactured by NRT. Distributed from 1980 to 2006 inclusive. Risk of injury to patient and/or user due to the tube and detector arm dropping to the floor. The manufacturer has initiated a field safety corrective action that will prevent this. | 16/03/2015 |
| Select | NICAS-713 | MDA-2015-010 | PadPro and R2 multifunction electrodes manufactured by Conmed. Intended for use with the Philips Hea | PadPro and R2 multifunction electrodes manufactured by Conmed. Intended for use with the Philips HeartStart FR3 Defibrillators and FRx AEDS. Risk of delay to shock. This is because specific electrodes manufactured by Conmed are now incompatible with some models of Philips defibrillators. | 12/03/2015 |
| Select | NICAS-712 | MDA-2015-009 | Defibrillation electrodes for children manufactured by Leonhard Lang. Supplied under various brand n | Defibrillation electrodes for children manufactured by Leonhard Lang. Supplied under various brand names and product codes. The manufacturer is recalling specified lots of defibrillation electrodes for children. Electrodes older than 2 years may malfunction and this could delay urgent treatment. | 05/03/2015 |
| Select | NICAS-711 | MDA-2015-008 | Breathing system components. Various product codes and specific batches. Manufactured by Inmed, supp | Breathing system components. Various product codes and specific batches. Manufactured by Inmed, supplied by Teleflex. Risk of interruption to anaesthesia and/or ventilation due to cracks in the corrugated flex tube. The manufacturer is recalling affected devices. | 03/03/2015 |
| Select | NICAS-710 | MDA-2015-007 | Vyclic Colour 3-way stopcock 2FL/1ML manufactured by Vygon | Vyclic Colour 3-way stopcock 2FL/1ML manufactured by Vygon. The manufacturer is recalling these devices as the paper side of the primary packaging could be punctured, compromising sterility. | 25/02/2015 |
| Select | NICAS-709 | MDA-2015-006 | Medical devices supplied by Atrium Medical a subsidiary of Maquet | Medical devices supplied by Atrium Medical a subsidiary of Maquet. Guidance for healthcare professionals who have received a Food and Drug Administration (FDA) Consent Decree from Maquet regarding its subsidiary Atrium Medical. | 20/02/2015 |
| Select | NICAS-708 | MDA-2015-005 | CEMTM nosecones for use with CUSA® Excel/Excel+ ultrasonic aspirator. Manufactured by Integra LifeSc | CEMTM nosecones for use with CUSA® Excel/Excel+ ultrasonic aspirator. Manufactured by Integra LifeSciences. Risk of burns to patient or user if the blue COAG button on the CUSA Excel CEM nosecone sticks in the ‘activated’ position. | 18/02/2015 |
| Select | NICAS-704 | MDA-2015-004R | Endobronchial tubes, various product codes. Manufactured by Teleflex Medical. | Endobronchial tubes, various product codes. Manufactured by Teleflex Medical. Potential failure to ventilate the patient if the Cobb connector detaches from the main connector. This could lead to hypoxia and hypercarbia if not immediately detected and corrected. The manufacturer is recalling affected products. | 06/02/2015 |
| Select | NICAS-703 | MDA-2015-004 | Endobronchial tubes, various product codes. Manufactured by Teleflex Medical. | Endobronchial tubes, various product codes. Manufactured by Teleflex Medical. Potential failure to ventilate the patient if the Cobb connector detaches from the main connector. This could lead to hypoxia and hypercarbia if not immediately detected and corrected. The manufacturer is recalling affected products. | 04/02/2015 |
| Select | NICAS-701 | MDA-2015-003 | Negative pressure wound therapy. Renasys™ range manufactured by Smith & Nephew. | Negative pressure wound therapy. Renasys™ range manufactured by Smith & Nephew. Risk of maceration, infection, loss of negative pressure or unrecognised bleeding in wounds if there is a blockage in the vacuum system of affected devices. | 21/01/2015 |
| Select | NICAS-700 | MDA-2015-002 | HomeChoice automated peritoneal dialysis system and HomeChoice PRO automated peritoneal dialysis sys | HomeChoice automated peritoneal dialysis system and HomeChoice PRO automated peritoneal dialysis system. Manufactured by Baxter Healthcare Ltd. The manufacturer has added to and updated warnings and cautions for patients, clinicians and carers using these devices. | 20/01/2015 |
| Select | NICAS-699 | MDA-2015-001 | All Accu-Chek Spirit Combo insulin infusion pumps. Manufactured by Roche Diagnostics Ltd. | "All Accu-Chek Spirit Combo insulin infusion pumps. Manufactured by Roche
Diagnostics Ltd. Risk of hyperglycaemia or hypoglycaemia if the pump’s power is interrupted." | 16/01/2015 |
| Select | NICAS-698 | MDA-2014-048 | IW900-series infant warmers. Manufactured by Fisher and Paykel Healthcare. Specific model and lot nu | "IW900-series infant warmers.
Manufactured by Fisher and Paykel Healthcare. Specific model and lot numbers are affected. Risk of serious injury to the infant in the warmer. The heater head may partially detach due to a manufacturing fault where the nut securing the heater head may break. Fisher and Paykel Healthcare issued a Field Safety Notice (FSN) dated 13 November and provided replacement nuts to customers affected but has not had enough replies to know that users have received and acted on this." | 18/12/2014 |
| Select | NICAS-697 | MDA-2014-047 | Autopen insulin pen injection devices. Manufacturer: Owen Mumford. | Autopen insulin pen injection devices. Manufacturer: Owen Mumford. Risk of hyperglycaemia, which could lead to immediate and long-term deterioration of health. Affected devices may have a mechanical fault which could cause the dose selector to revert to zero resulting in the devices not delivering the correct dose of insulin. | 17/12/2014 |
| Select | NICAS-696 | MDA-2014-046 | Counterfeit Toshiba Ultrasound Transducers | "Counterfeit ultrasound transducers have been supplied to 2 hospitals.
These devices may not meet the performance specified by Toshiba. There have been no reports of patient harm.
Transducers supplied directly by Toshiba Medical Systems UK are not affected." | 08/12/2014 |
| Select | NICAS-695 | MDA-2014-045 | Central venous catheters:Multicath Expert 5 lumen (9.5FG/16cm) | "Central venous catheters:
Multicath Expert 5 lumen (9.5FG/16cm)
Manufactured by Vygon.
Product code: 8159.167. Risk of incorrect placement of catheter and delay to treatment. This is due to a manufacturing problem resulting in: decreased length of the catheter. The catheter tip may not reach the desired position during placement : catheters with four lumens (instead of five). This may then require additional catheter or extension sets after placement.
Vygon has issued a Field Safety Notice (FSN), dated 16 September 2014, to its customers recalling affected catheters but has not received enough replies to assure themselves that users have received and acted on this information.
Lot/batch number: 020414GE" | 03/12/2014 |
| Select | NICAS-694 | MDA-2014-044 | Mains power lead used with Omnifuse syringe pumps (all models). Part number 0151-0651. Manufactured | Mains power lead used with Omnifuse syringe pumps (all models). Part number 0151-0651. Manufactured by Smiths Medical International Ltd. Risk of interruption or delay in therapy due to incorrect design of the mains lead supplied by Smiths Medical. Smiths Medical Ltd has issued a Field Safety Notice (FSN), dated November 2014, to its customers recalling affected products but hasn’t had enough replies to know that users have received and acted on this information. The original FSN was sent in September 2014. The manufacturer recently identified that more customers were affected and so has issued this second FSN. These 2 FSNs provide the same information. | 26/11/2014 |
| Select | NICAS-693 | MDA-2014-043 | Philips Healthcare - Gel-E Donut and Squishon 2 | "Neonatal and paediatric support devices. All batches of:
Gel-E Donut part numbers: 92025-A, 92025-B, 92025-C and Squishon 2 part number 91033-2.
Manufactured by Philips Healthcare (Children’s Medical Ventures)
Risk of infection, breathing difficulties and allergic reactions." | 25/11/2014 |
| Select | NICAS-691 | MDA-2014-042 | Hudson RCI nebulizer adaptors and Aquapak sterile water with nebulizer adaptors | "Hudson RCI© nebulizer adaptors and Aquapak sterile water with nebulizer adaptors.
Manufactured by Teleflex Medical.
Specific product and lot numbers.
The packaging of these devices might not be sealed properly." | 04/11/2014 |
| Select | NICAS-690 | MDA-2014-041 | Babytherm infant warmers and open infant care units for newborns. Manufactured by Draeger Medical. M | "Risk of baby falling out of the device.
Failure to follow the instructions for use for inserting the inner safety panels and locking the outer safety side panels may result in them opening unexpectedly.
Draeger sent a Field Safety Notice to its customers in August 2014 but hasn’t had enough replies to know if users have received and acted upon this information." | 21/10/2014 |
| Select | NICAS-689 | MDA-2014-040 | LIFEPAK® 1000 defibrillator. Manufactured by Physio-Control. All serial numbers. | "LIFEPAK® 1000 defibrillator. Manufactured by Physio-Control. All serial numbers. Risk of failure to deliver a shock. This is due to unexpected shut down of the defibrillator caused by a battery with very low charge.
Confusing instructions for use mean that batteries aren’t always replaced when they have a low or very low charge.
See the Field Safety Notice for further details." | 09/10/2014 |
| Select | NICAS-687 | MDA-2014-038 | Gel-E Donut and Squishon 2, Neonatal and paediatric support devices. Manufactured by Philips Healthc | "Risk of infection, breathing difficulties and allergic reactions.
Philips Healthcare (Children’s Medical Ventures) has become aware of mould growth on these neonatal and paediatric support devices. The mould has been identified as Cladosporium and Penicillium Fungi." | 30/09/2014 |
| Select | NICAS-685 | MDA-2014-036 | Portex endotracheal tube holder | "Portex® endotracheal tube holder (2.5mm and 3.0mm) sold as stand-alone products or packaged in intubation kits.
Manufactured by Smiths Medical.
Specific product codes and lot numbers.
Risk of extubation or delay to therapy as there may be difficulty passing a suction catheter through the endotracheal tube when the holder is locked. There may also be difficulty locking the holder." | 17/09/2014 |
| Select | NICAS-683 | MDA-2014-034 | Microtek Medical - Basin-bowl liner or equipment cover | "Microtek Medical - Basin-bowl liner or equipment cover (Drape)
Product codes: 17700, 16700A, 3109N, 3109NT, 3108N, 33099, 9386001, 3309N, TP1909A, TP1909B.
All lot numbers.
The manufacturer has found that some of these devices within the above product codes may have small cracks or holes. This could compromise the sterile field." | 27/08/2014 |
| Select | NICAS-681 | MDA-2014-032 | Gastrostomy devices: 1.Measuring device – product code: BM01 2.Direct dilation kit – product codes: | "Gastrostomy devices:
1.Measuring device – product code: BM01
2.Direct dilation kit – product codes: DD12fr, DD14fr and DD16fr
3.Balloon gastrostomy kit – product codes: EK12fr, EK14fr, EK16fr, EK18fr, EK20fr, EK22fr and EK24fr
All batches. Manufactured by Medicina Ltd.
Risk of infection as the balloon gastrostomy kit may contain out-of-date devices. The sterility of these devices cannot be assured. In addition, the safety and performance of these devices has not been properly evaluated and so the CE marking of all of these devices is invalid.
Medicina issued three Field Safety Notices (FSNs) in June 2014 but has not had sufficient confirmation that customers have received and acted on these notices" | 20/08/2014 |
| Select | NICAS-682 | MDA-2014-033 | Insulin syringe 1ml safety syringe 27G (for professional use). | "Insulin syringe 1ml safety syringe 27G (for professional use). Product code: RN01/27i.
All batches. Manufactured by Medicina Ltd. The affected devices are unable to deliver fewer than 7 units of insulin.
In addition, the safety and performance of these devices has not been properly evaluated and so the CE marking of all of these devices is invalid.
Medicina issued a Field Safety Notice in June 2014 but has not had sufficient confirmation that customers have received and acted on these notices." | 20/08/2014 |
| Select | NICAS-680 | MDA-2014-031 | Surgical instrument: Standard Offset Cup Impactor manufactured by Greatbatch, distributed in the UK | Surgical instrument: Standard Offset Cup Impactor manufactured by Greatbatch, distributed in the UK by JRI Limited and Stryker UK Limited. All lots. Potential for infection from inadequately sterilized devices. The manufacturer has validated new sterilization parameters for these devices to address this issue. These parameters are provided in the manufacturer’s Field Safety Notice (FSN) issued in March 2014. | 24/07/2014 |
| Select | NICAS-678 | MDA-2014-029 | Ventstar disposable breathing systems manufactured by Draeger, Part numbers 2M86841 and 2M86791. | "Ventstar disposable breathing systems. Part numbers 2M86841 and 2M86791.
Manufactured by Draeger.
Specific batch numbers affected.
Risk of inhalation of foreign particles.
Due to a manufacturing issue, there is the potential for loose adhesive residue to be inside the breathing systems. This may enter the lungs if affected devices are used." | 23/07/2014 |
| Select | NICAS-679 | MDA-2014-030 | External fixators. Manufactured by DePuy Synthes. | "External fixators. Synthes trauma external fixation system(small, medium, distraction osteogenesis (DO) ring and large)
Manufactured by DePuy Synthes. Specific part numbers affected. The instructions for use have changed. These devices are now identified as being ‘MR-Conditional’. This places additional restrictions on patient positioning. Failure to follow the updated instructions may result in patient harm. DePuy Synthes issued a second Field Safety Notice (FSN) dated 4 July 2014, which is an extension to their original Field Safety Notice (FSN) dated 14 April 2014." | 23/07/2014 |
| Select | NICAS-676 | MDA-2014-028 | Procedure packs containing various central venous catheters | "Update to MDA/2014/022.
Procedure packs containing various central venous catheters:
pressure injectable, multi-lumen and multi-lumen with Arrowg+ard® antimicrobial surface.
Specific product references and part numbers are affected.
Manufactured by Arrow International (a division of Teleflex).
Risk of incorrect lumen selection." | 11/07/2014 |
| Select | NICAS-675 | MDA-2014-027 | Breast Implants. All types, makes and models. | "Breast Implants. All types, makes and models. Since publishing MDA/2011/017 in February 2011 requesting healthcare professionals to report cases of anaplastic large cell lymphoma (ALCL) in women with breast implants we have received three reports of ALCL in the UK and more cases worldwide have been identified in the peer reviewed literature (see background).
The MHRA continues to collect and analyse information from UK healthcare professionals and other sources about this issue in order to build a fuller picture of the occurrence of this rare disease in association with breast implants.
The MHRA is issuing this alert to further encourage healthcare professionals to report cases of ALCL in women who have breast implants or who have had them removed." | 10/07/2014 |
| Select | NICAS-674 | MDA-2014-026 | Home use blood glucose meters: Accu-Chek Compact meter and test strips Accu-Chek Mobile meter and t | "Home use blood glucose meters: Accu-Chek Compact meter and test strips
Accu-Chek Mobile meter and test cassette
Accu-Chek Active meter and test strips manufactured by Roche. The Accu-Chek Compact, Accu-Chek Mobile and Accu-Chek Active devices may give falsely low blood glucose readings for patients receiving ceftriaxone therapy. Roche has updated product leaflets for these devices and issued a Field Safety Notice (FSN), distributed to healthcare professionals." | 09/07/2014 |
| Select | NICAS-673 | EFA-2014-002 - Addendum | EFA-2014-002 - Addendum - additional guidance for long stay environments | "EFA-2014-002 - Addendum - additional guidance for long stay environments.
Many long stay units, particularly mental health units have implemented smoke free policies for patients, staff and visitors. The use of e-cigarettes has formed part of implementation strategies for these policies. Restrictions on charging rechargeable e-cigarettes in these environments effectively restrict the use of these devices by patients, and the Department has been advised that a complete ban on recharging is not a workable solution to the hazards identified in EFA/2014/002" | 08/07/2014 |
| Select | NICAS-672 | MDA-2014-025 | Turning aids - ReTurn 7400 and ReTurn 7500 - Manufactured by Handicare AB | "Turning aids - ReTurn 7400 and ReTurn 7500 - Manufactured by Handicare AB.
The wing handle on the ladder part of the turning aid may become loose, with a risk of harm to the patient and the person operating the device." | 02/07/2014 |
| Select | NICAS-671 | MDA-2014-024 | HeartStart MRx defibrillator/monitor. Model numbers M3535A and M3536A with Q-CPR™ meter option B08. | "HeartStart MRx defibrillator/monitor.
Model numbers M3535A and M3536A with
Q-CPR™ meter option B08. Manufactured by Philips. Specific serial numbers affected.
Risk of delay in delivering CPR. When the HeartStart MRx is used with the Q-CPR meter in defibrillation mode, the meter
may incorrectly display the ‘Do Not Touch the Patient’ icon. Consequently, the user might not resume chest compressions in a timely manner, which could affect patient outcome. This problem can occur in AED or manual modes. Philips issued a Field Safety Notice dated April 2014 (reference FSN86100128A)." | 26/06/2014 |
| Select | NICAS-670 | MDA-2014-023 | Adaptors for Shelfpak humidifier and Aquapak sterile water manufactured by Teleflex Medical | "Adaptors for Shelfpak humidifier and Aquapak sterile water manufactured by Teleflex Medical.
Specific product and lot numbers.
The packaging of these devices might not be sealed properly." | 17/06/2014 |
| Select | NICAS-669 | EFA-2014-002 | E-cigarettes batteries and chargers | "E-cigarettes, batteries and chargers.
Includes reusable and disposable electronic cigarettes (e-cigarettes), cigars, pipes and similar battery powered tobacco replacement products which use a heating element (atomiser) to produce a vapour which resembles smoke.
Potential fire or explosion." | 16/06/2014 |
| Select | NICAS-668 | MDA-2014-022 | Central venous catheters: various pressure injectable, multi-lumen and multi-lumen with Arrowg+ard a | "Central venous catheters: various pressure injectable, multi-lumen and multi-lumen with Arrowg+ard antimicrobial surface. Specific product references and part numbers are affected. Manufactured by Arrow International (a division of Teleflex). Risk of incorrect lumen selection.
The extension lumen may have the wrong
exit (proximal, medial, distal) and size
printed on it, although the hub colour coding remains correct. For example the distal lumen may be printed with the words medial 18 GA instead of distal 16GA.
Arrow International issued a Field Safety
Notice (FSN) dated 15 May 2014." | 12/06/2014 |
| Select | NICAS-667 | MDA-2014-021 | Home use blood glucose meters - Accu Chek Mobile | "Home use blood glucose meters - Accu-Chek Mobile meter and Accu-Chek Mobile test cassette manufactured by Roche.
This device may give falsely high readings.
As a consequence, patients might take an inappropriately high dose of insulin." | 10/06/2014 |
| Select | NICAS-662 | MDA-2014-017 | Alaris SmartSite needle-free valve Product reference: 2000E7D. Manufactured by CareFusion. Specific | "Alaris SmartSite needle-free valve
Product reference: 2000E7D Manufactured by CareFusion. Specific lot numbers. Risk of disconnection or inability to disconnect
from the SmartSite could result in delay to
treatment due to: air entering the fluid path, replacement of a central catheter or
PICC, under-delivery and leakage of
medication. CareFusion issued a Field Safety Notice (FSN) in February 2014 providing advice on this problem." | 21/05/2014 |
| Select | NICAS-661 | MDA-2014-016 | Reusable latex breathing bags. Manufactured by Dräger. Specific part numbers affected. | "Reusable latex breathing bags.
Manufactured by Dräger. Specific part numbers affected. Potential for acute allergic reaction in staff or patients after using a Dräger latex breathing bag. These breathing bags are marked ‘NR’ for
natural rubber (latex) but this may not be
immediately obvious to the user." | 15/05/2014 |
| Select | NICAS-658 | MDA-2014-013 | Pride Mobility Products Ltd - S74 Elite Sport Scooter with Leoch 20 amp-hour batteries | "Pride Mobility Products Ltd - S74 Elite Sport Scooter with Leoch 20 amp-hour batteries.
Risk of the scooter batteries overheating and swelling during the charging cycle. This may result in a reduced range of travel or a failure of the scooter to drive as expected." | 28/04/2014 |
| Select | NICAS-659 | MDA-2014-014 | HeartSine Technologies - Samaritan - PAD 500P | "HeartSine Technologies - Samaritan - PAD 500P
Specific serial numbers affected.
Risk of failure to deliver therapy." | 28/04/2014 |
| Select | NICAS-655 | MDA-2014-012 | Laboratory reagents requiring manual handling for use in combination with cobas c 502 analyser made | "Laboratory reagents requiring manual handling for use in combination with cobas c 502 analyser made by Hitachi supplied by Roche. The level sensing function of the cobas c502 laboratory analyser has not been activated for tests requiring manual reagent handling. The use of insufficient volumes of reagent may lead to a false negative result and a missed diagnosis, such as syphilis. It is possible to obtain ‘valid’ but inaccurate results
when there is no reagent remaining in the Roche cassette. Since we issued a notice in February 2012 (MDA/2012/004) the settings for level sensing have not been correctly encoded in some REC files,
therefore level sensing may not have been
correctly performed on cobas c502 analysers." | 16/04/2014 |
| Select | NICAS-653 | MDA-2014-011 | Powered Wheelchairs manufactured by Pride Mobility Products | "Powered wheelchairs manufactured by Pride Mobility Products Ltd. All models suitable for occupied use in vehicles are affected. Potential for injury should wheelchairs be secured into vehicles incorrectly. Pride Mobility has updated their transportation documentation (dated September 2013) this includes safety-critical information. In particular, the guidance on how to secure powered
wheelchairs requiring more than four tie-downs has been clarified. Pride Mobility issued a Field Safety Notice in October 2013. However, it is not clear whether
users have received and acted upon this new guidance." | 24/03/2014 |
| Select | NICAS-651 | MDA-2014-009 | FreeStyle Mini and FreeStyle blood glucose monitoring systems manufactured by Abbott Diabetes Care. | "FreeStyle Mini and FreeStyle blood glucose monitoring systems manufactured by Abbott Diabetes Care. These blood glucose meters may give incorrect low blood glucose results when they are used
with FreeStyle Lite and FreeStyle blood glucose test strips. Abbott Diabetes Care is therefore asking people to stop using these affected meters and to contact them to get a replacement. The manufacturer has sent Field Safety Notices, dated 19 February 2014, to customers. To deal with this problem when using FreeStyle
Navigator continuous glucose monitoring system (1.0 and 1.5 generation) and the FreeStyle blood glucose meter built into the OmniPod insulin management system, follow the advice in the manufacturer’s Field Safety Notice." | 13/03/2014 |
| Select | NICAS-652 | MDA-2014-010 | Infusion pumps - GemStar infusion system. Manufactured by Hospira. List numbers: 13000, 13100, 13150 | "Infusion pumps - GemStar infusion system. Manufactured by Hospira. List numbers: 13000, 13100, 13150. Risk of delay to patient therapy due to loss of audio alarms. The connection between the beeper subassembly and pump may fail so that only visual alarms will be available.
The pump will only identify the beeper failure during ‘self-test’ whilst powering up, which will prevent it from being programmed or used. Pumps that were previously fixed for this beeper failure may fail again." | 13/03/2014 |
| Select | NICAS-649 | EFA-2014-001 | Biomass boilers which have a slumber-kindle mode status | "Biomass boilers which have a slumber-kindle mode status.
Operation in slumber/kindle mode may allow any pellets held within the combustion chamber to continue to burn and depending on the design and setup of the boiler installation this may generate:
• | 11/03/2014 |
| Select | NICAS-648 | MDA-2014-007 | Peristeen anal irrigation system manufactured by Coloplast Limited. | "Peristeen anal irrigation system
manufactured by Coloplast Limited. Risk of using transanal irrigation inappropriately.
The manufacturer has updated the instructions for use including changes to the indications, contraindications, precautions and warning sections. More detailed instructions for patient
examination before starting transanal irrigation have been added.
The MHRA is issuing this MDA to help bring the changes to the attention of the relevant healthcare professionals, suppliers and end users." | 27/02/2014 |
| Select | NICAS-647 | MDA-2014-006 | Electrosurgical devices. CUSA CE nosecones for use with the CUSA Excel/Excel+ ultrasonic aspirator. | "Electrosurgical devices.CUSA CEM nosecones for use with the CUSA Excel/Excel+ ultrasonic aspirator. Product codes: C6623 and C6636. Manufactured by Integra Lifesciences. Risk of burns to patient or user. The manufacturer has identified that the blue COAG button on the CUSA® Excel CEM™ nosecone could stick in the ‘activated’ position.
This failure can occur whist the device is being used with the CUSA® Excel/Excel+ ultrasonic aspirator. Integra Lifesciences is in the process of modifying the design to mitigate the risk of failure. The new design will not be available before the end of September 2014." | 26/02/2014 |
| Select | NICAS-643 | MDA-2014-003 | Single-use syringes: Plastipak 50ml Luer Lok. Manufactured by BD Medical. | "Single-use syringes: Plastipak 50ml Luer Lok. Manufactured by BD Medical.Product codes affected: 300223 non sterile, 300865 sterile (NHS Supply Chain code FWC034 England only), 300869 Amber – sterile. All lot numbers are affected. Risk of delay or interruption to treatment when
these syringes are used in power-driven syringe pumps. BD continues to receive reports of occlusion alarms triggering due to an increased plunger movement force, which was introduced by a design change in April 2012. BD is in the process of modifying the design to lower plunger forces. The new design will not be
available before the end of January 2014." | 17/01/2014 |
| Select | NICAS-642 | MDA-2014-002 | Workstation software for computed tomography systems: VitreaCore® software versions 6.0 to 6.5 inclu | "Workstation software for computed tomography systems: VitreaCore® software versions 6.0 to 6.5 inclusive, including all upgrades (except 6.3.1, 6.4.4 and 6.4.5). Manufactured by Vital Images. Risk of patient misdiagnosis or inappropriate treatment due to incorrect image orientation marking. This may occur when loading a study into the 3D viewer in VitreaCore, taking a 16-bit secondary capture snapshot of the study and
loading this snapshot in a DICOM viewer.
Vital Images has provided advice on how to
confirm that snapshots are correctly marked." | 07/01/2014 |
| Select | NICAS-641 | MDA-2014-001 | OPTEASE retrievable vena cava filter manufactured by Cordis Corporation | OPTEASE retrievable vena cava filter, manufactured by Cordis Corporation. Risk of serious patient injury from the migration of a wrongly orientated inferior vena cava (IVC) filter. | 02/01/2014 |
| Select | NICAS-640 | MDA-2013-086 | Pressure reducing air mattresses: ClinActiv and ClinActiv Plus Therapy Surface | "Pressure reducing air mattresses: ClinActiv and ClinActiv Plus Therapy Surface. Manufactured by Hill-Rom.
Models N02050, N02051, P02062, P02063, P02064 and P02065. All serial numbers are affected. Silicone oil may leak out of the pressure sensor of the mattress and spill onto the floor. Patients or carers may slip in the oil and injure themselves. The manufacturer has developed instructions
on how to clean up these leaks but they were not included in the Field Safety Notice dated 22 July 2013. In addition, the manufacturer has not received sufficient confirmation from users that they have
received and acted upon this information.
The MHRA remains in discussion with Hill-Rom about its corrective actions and sensor
replacements." | 20/12/2013 |
| Select | NICAS-639 | MDA-2013-085 | GemStar docking station for use with specific GemStar infusion pumps. | "GemStar docking station for use with specific GemStar infusion pumps.
Manufactured by Hospira.
Potential for a delay in infusion therapy.
Two problems exist - when the docking station is used in conjunction with a Gemstar phase 3 infusion pump, the pump may fail to power up. when the Gemstar phase 4 infusion pump is used in conjunction with both a docking
station and an external battery accessory,
this configuration could generate an error
code 11/003, which could stop a running
infusion.
The manufacturer issued a Field Safety Notice(FSN) dated 24 October 2013 but has notreceived sufficient confirmation that it has been received and acted upon." | 19/12/2013 |
| Select | NICAS-637 | MDA-2013-083 | TransRadial artery access kit. Manufactured by Arrow International (a division of Teleflex Medical). | "TransRadial artery access kit.
Manufactured by Arrow International
(a division of Teleflex Medical).
Specific part numbers and lot numbers.
Risk of delay to patient treatment.
Arrow International are recalling certain models and lot numbers of their TransRadial artery access kits because the introducer needles packaged within the kits can be partially or fully occluded.
Arrow International issued a Field Safety Notice (FSN) dated 09 October 2013. The FSN lists the part and lot numbers that are affected. The manufacturer has not received sufficient confirmation that this FSN had been received and acted upon." | 13/12/2013 |
| Select | NICAS-636 | MDA-2013-082 | FreeStyle Lite home use blood glucose test strips. | "FreeStyle Lite home use blood glucose test stripsmanufactured by Abbott Diabetes Care, used with FreeStyle, FreeStyle Mini and FreeStyle Navigator blood glucose meters (manufactured by Abbott Diabetes Care) the FreeStyle blood glucose meter built into the OmniPod insulin management system (manufactured by Insulet Corporation).
Affected test strips may produce erroneously low blood glucose results and may give out-of-range control solution results when used with the specified blood glucose meters. There are no other Abbott Diabetes Care strip lots or products affected by this issue. The manufacturer has sent Field Safety Notices, dated 14 November 2013." | 06/12/2013 |
| Select | NICAS-635 | MDA-2013-081 | Intravenous pump set: Lifeshield Primary Plumset. Manufactured by Hospira. Specific list numbers and | "Intravenous pump set: Lifeshield Primary Plumset. Manufactured by Hospira. Specific list numbers and lot numbers are affected.
Risk of embolism and allergic reaction due to exposure to particulates and non-biocompatible materials, especially during administration of parenteral lipids.
Due to a manufacturing fault, these devices
may be fitted with an incorrect filter which has not undergone biocompatibility testing.
Hospira issued a Field Safety Notice (FSN)
dated 22 October 2013, but has not received confirmation from enough users that they have received and acted on this information." | 05/12/2013 |
| Select | NICAS-634 | MDA-2013-080 | Perfusor Space infusion pump. Manufactured by B Braun. | "Perfusor Space infusion pump. Manufactured by B Braun. Risk of interruption of therapy when changing
syringe. If an aged battery (4 years or older) is used, the pump may not have sufficient power to perform a syringe change, despite the battery indicator
on the pump showing a full charge. This could lead to the therapy unexpectedly stopping. The problem does not arise if the pump is plugged into the mains electrical supply. Please see the manufacturer’s Field Safety Notices (technical or clinical)." | 21/11/2013 |
| Select | NICAS-632 | MDA-2013-079 | Intravenous administration sets: Primary PlumSet Clave secondary port. Manufactured by Hospira. | "Intravenous administration sets: Primary PlumSet Clave secondary port. Manufactured by Hospira. Specific list numbers are affected. Risk of interruption to IV therapy, which may require medical intervention. This is due to leakage of fluids from the break in the bond between the Clave needle-free connector and the secondary port of the PlumSet.
Hospira issued a Field Safety Notice (FSN)
dated 08 August 2013 to advise users how to minimise the possibility of breakage, but has not received confirmation from enough users that they have received and acted on this information." | 13/11/2013 |
| Select | NICAS-630 | MDA-2013-077 | Receptal suction canisters and liners. Manufactured by Hospira (formerly manufactured by Abbott). Al | "Receptal suction canisters and liners.
Manufactured by Hospira (formerly manufactured by Abbott). All Abbott and Hospira list numbers are affected.
All lot numbers and sizes are affected. Potential for failure or loss of suction if a
canister and liner of different sizes are used in combination. Due to a number of customer complaints, Hospira has issued a Field Safety Notice (dated 06 September 2013) to advise customers of appropriate use and combination of liners and
canisters. The MHRA is not confident that Hospira has been able to reach all affected customers." | 31/10/2013 |
| Select | NICAS-629 | MDA-2013-076 | Ultrasound probe cover: burr hole probe cover with gel. Manufactured by Microtek Medical Europe, a d | "Ultrasound probe cover: burr hole probe cover with gel. Manufactured by Microtek Medical Europe, a division of Ecolab.
Product reference (SKU number): 3688UK, PC3688, PC3688EU. Risk of exposure to endotoxin levels above acceptable limits if the ultrasound probe cover comes into contact with the central nervous system.
The manufacturer has identified that the
affected ultrasound probe covers have not
undergone adequate endotoxin testing.
Microtek Medical Europe issued a Field Safety Notice (FSN) dated 10 July 2013 but has not received sufficient confirmation from users that they have received and acted on this information." | 24/10/2013 |
| Select | NICAS-628 | MDA-2013-075 | Vacutainer ® multiple sample Luer adaptor for blood sample collection. Specific lot numbers affected | "Vacutainer ® multiple sample Luer adaptor for blood sample collection. Specific lot numbers affected. Manufactured by Becton, Dickinson and Company (BD). Increased risk to users of exposure to blood, and a risk of under filling blood collection tubes which could lead to unexpected results in some laboratory tests. This problem was first identified in May 2013 (see BD’s Field Safety Notice and the MHRA’s MDA/2013/061). BD has now identified that further lots are affected and has issued a second Field Safety Notice providing full details of all affected lots.
BD has received reports where the retractable sleeve, which covers the non-patient cannula before and after a blood collection tube is filled, has either failed to recover on removal of the sample tube, leaked, or fallen off. Reports have also been received of leakage at the Luer tip
connection." | 16/10/2013 |
| Select | NICAS-626 | MDA-2013-073 | Pressure relieving air mattresses and overlays. All models and manufacturers. | "Pressure relieving air mattresses and overlays. All models and manufacturers. Risk of fatality from house fire.
The MHRA is aware of fatal domestic house fires starting from lit cigarettes being dropped onto non-fire-retardant bedding covering air mattresses and air overlays.
This resulted in a breach of the mattress or overlay material, and leakage of the pumped air aided combustion and the spreading of the fire.
Note - The MHRA does not possess a list of manufacturers or suppliers of these devices." | 10/10/2013 |
| Select | NICAS-627 | MDA-2013-074 | BD Neoflon IV cannula. Manufactured by Becton Dickinson. All lots of: Product code: 391350, size: 24 | "BD Neoflon IV cannula. Manufactured by Becton Dickinson. All lots of: Product code: 391350, size: 24 G, NHSSC code: FSP070. Product code: 391349, size: 26 G.
Risk of delay in treatment due to increased risk of the catheter buckling during initial puncture of skin. Due to a change in manufacturing process, the manufacturer has become aware of an increase in reported incidents of the catheter buckling in use. Becton Dickinson does not currently have stock available to replace affected devices. New product is being manufactured and should be available for supply from the beginning of
October. Becton Dickinson has not issued a Field Safety Notice in relation to this issue." | 10/10/2013 |
| Select | NICAS-625 | MDA-2013-072 | Implantable cardioverter defibrillators (ICD) and cardiac resynchronisation therapy devices (CRT-D). | "Implantable cardioverter defibrillators (ICD) and cardiac resynchronisation
therapy devices (CRT-D). COGNIS CRT-Ds and TELIGEN ICDs. Manufactured by Boston Scientific. Risk of loss of CRT/ICD therapy due to rapid battery depletion as a result of capacitor degradation occurring
in a subset of devices manufactured prior to December 2009." | 27/09/2013 |
| Select | NICAS-624 | MDA-2013-071 | Growth hormone pens. NordiPen used with 5mg and 10mg Norditropin SimpleXx (somatropin) and NordiPenM | "Growth hormone pens. NordiPen used with 5mg and 10mg Norditropin SimpleXx
(somatropin) and NordiPenMate.
Manufactured by Novo Nordisk." | 05/09/2013 |
| Select | NICAS-621 | MDA-2013-069 | Vacutainer Flashback blood collection needle 21G. Catalogue number 301746. Specific lot numbers are | "Vacutainer Flashback blood collection needle 21G.Catalogue number 301746. Specific lot numbers are affected. Manufactured by Becton, Dickinson and Company (BD). Risk to users of exposure to blood. BD has received reports of blood leakage near the flash chamber of affected devices, caused by a moulding defect.
BD has issued a Field Safety Notice (FSN)
dated 05 July 2013, recalling affected devices." | 28/08/2013 |
| Select | NICAS-622 | MDA-2013-070 | Insulin infusion sets and reservoirs used with Paradigm ambulatory insulin pumps (manufactured by Me | "Insulin infusion sets and reservoirs used with Paradigm ambulatory insulin pumps (manufactured by Medtronic): 1) Paradigm infusion sets (all MMT models, all lot numbers). 2) Paradigm insulin reservoirs (MMT models - 326A and 332A, specific lots). See below for details of model and lot numbers for both products. Risk of under- or over-delivery of insulin, which may lead to hypoglycaemia or hyperglycaemia, with a consequent loss of consciousness or death, in extreme
cases. The root causes are:
1) Spillage from the insulin reservoir may block connector vents, preventing correct priming of the pump. Medtronic have issued advice on the correct technique for filling the reservoir.
2) The insulin reservoir may leak, due to a
manufacturing defect, which may result in under delivery of insulin and failure of the pump’s occlusion alarm. Medtronic have initiated a recall of affected reservoirs." | 28/08/2013 |
| Select | NICAS-620 | MDA-2013-068 | Single use syringes: PlastipakTM 50ml Luer Lok syringe – sterile. Manufactured by BD Medical. | "Single use syringes: PlastipakTM 50ml Luer Lok syringe – sterile. Manufactured by BD Medical. Product code 300865. (England only - NHS Supply Chain code FWC034). Specific lot numbers are affected.
Risk of under-delivery of medication to patient. Syringes from the affected batches may have a dent/indentation on the syringe barrel which may cause leakage inside the syringe, between the plunger and the barrel. BD issued a Field Safety Notice (FSN) on 24 June 2013 recalling the batches affected by this manufacturing problem.
Note: This notification is different from the earlier recall of PlastipakTM 50ml Luer Lok syringes initiated by BD in April 2013 (MDA/2013/024)." | 21/08/2013 |
| Select | NICAS-619 | MDA-2013-067 | Vygon - Protect-A-Line IV extension set | "Vygon - Protect-A-Line IV extension set.
Risk of air embolus because affected devices have been supplied with vented caps on the female port (Y-site) instead of non-vented caps." | 19/08/2013 |
| Select | NICAS-618 | MDA-2013-066 | HeartStart XL defibrillator/monitor with M3516A batteries of lot number with ‘LK’ prefix. Manufactur | "HeartStart XL defibrillator/monitor with M3516A batteries of lot number with ‘LK’ prefix. Manufactured by Philips. Distributed by Philips and Cardiac Services UK & Ireland. Defibrillator battery life has been reduced from 1.5 years to 1 year and the capacity test interval has been reduced from six months to three months. This applies to new batteries with the lot number prefix ‘LK’. Philips is supplying an addendum with battery orders and HeartStart XL monitor/defibrillator
orders stating these changes (March 2013) to HeartStart XL instructions for use (edition 7) and HeartStart XL service manual (edition 6)." | 15/08/2013 |
| Select | NICAS-616 | MDA-2013-064 | Home use blood glucose test strips. GlucoMen LX Sensor blood glucose test strips 50 count (product c | "Home use blood glucose test strips.
GlucoMen LX Sensor blood glucose test strips 50 count (product code 38877), used with the GlucoMen LX and GlucoMen LX PLUS meter manufactured by Menarini. Lot 3212214249, expiry date 31-08-2014
and lot 3212219249, expiry date 31-08-2014. Affected lots have been contaminated during manufacture, and may give an overestimation of blood glucose levels, potentially resulting in
inappropriate insulin administration.
The manufacturer distributed the affected lots in the UK via wholesale outlets during October and November 2012. The product may, however, still remain with users or pharmacies. There is currently no evidence that UK patients have been affected." | 14/08/2013 |
| Select | NICAS-617 | MDA-2013-065 | Procedure packs containing BD Plastipak 50 ml Luer Lok syringe. Manufactured by Kimal. Specific prod | "Procedure packs containing BD Plastipak 50 ml Luer Lok syringe. Manufactured by Kimal. Specific product codes and lot numbers are affected (see Appendix).Risk of delay or interruption to treatment when
affected syringes are used in power-driven
syringe pumps. A change to the design of the syringe plunger in April 2012 may have required syringe pump occlusion alarm settings to be adjusted to avoid false occlusion alarms Use of older design syringes in pumps that have been adjusted can result in a delay to the occlusion alarm being triggered. Kimal is recalling procedure packs containing
BD syringes of the old design to avoid this
risk. This issue is related to MDA/2013/024." | 14/08/2013 |
| Select | NICAS-615 | MDA-2013-063 | TRACOE twist tracheostomy tubes distributed in the UK by Kapitex Healthcare Ltd | "TRACOE twist tracheostomy tubes distributed in the UK by Kapitex Healthcare Ltd.
Risk of delay in treatment.
Difficulty changing the inner cannula as the locking system can be too tight." | 13/08/2013 |
| Select | NICAS-614 | MDA-2013-062 | Infusion pumps: Alaris GP, GP Guardrails, GP Plus and GP Plus Guardrails. Manufactured by CareFusion | "Infusion pumps: Alaris GP, GP Guardrails, GP Plus and GP Plus Guardrails
Manufactured by CareFusion.
Specific serial numbers are affected.
Risk of interruption to therapy. A fault with the front and rear bearings of the pump’s stepper motor may cause the pump to stall during an infusion. The pump stops, alarms and displays a ‘DRV1’ or ‘DRV2’ error on the screen. Replacement of the motors will begin in September 2013. CareFusion issued a Field Safety Notice (FSN) in May 2013." | 08/08/2013 |
| Select | NICAS-611 | MDA-2013-059 | Orthopaedic instrument. Flexible handle (part no. 355.280), used with the Simplified Universal Nail | "Orthopaedic instrument. Flexible handle (part no. 355.280), used with the Simplified Universal Nail System (SUN) and the Universal Nail System (UNI). Manufactured by Synthes GmbH.
Due to the design of the instrument, the device may not be adequately cleaned. This could result in a risk of infection to the patient. The manufacturer has redesigned the affected part and issued a Field Safety Notice advising on the replacement and return of the affected device." | 01/08/2013 |
| Select | NICAS-613 | MDA-2013-061 | Vacutainer® multiple sample Luer adaptor for blood sample collection. Catalogue number 367300 (Engla | "Vacutainer® multiple sample Luer adaptor for blood sample collection. Catalogue number 367300 (England only - NHS Supply Chain code KFK036). Specific lot numbers are affected. Manufactured by Becton, Dickinson and Company (BD). Increased risk to users of exposure to blood, and a risk of underfilling of blood collection tubes which could lead to unexpected results in some laboratory tests. BD has received reports where the retractable sleeve, which covers the non-patient cannula before and after a blood collection tube is filled, has either failed to recover on removal of the sample tube, leaked, or fallen off. Reports have
also been received of leakage at the Luer tip connection. BD has issued a Field Safety Notice with advice to users, and will replace products from affected lot numbers on request." | 01/08/2013 |
| Select | NICAS-610 | MDA-2013-058 | Blood grouping cassettes.OrthoBioVue multi-reagent cassettes. Manufactured by Ortho Clinical Diagnos | "Blood grouping cassettes.OrthoBioVue multi-reagent cassettes. Manufactured by Ortho Clinical Diagnostics. Specific lots.
A small number of multi-reagent cassettes in affected lots have been found with labels
containing product information on the wrong side of the cassette.
The use of affected multi-reagent cassettes
may lead to false negative or false positive
results, causing a potential misclassification of the patient or donor blood groups or Rh/K phenotypes or incorrect antibody detection results. This may be of particular clinical concern where there is no confirmation of the group (e.g. in testing of newborns or where reverse grouping is not in place).
Ortho Clinical Diagnostics have sent out a
Field Safety Notice having identified the cause of the manufacturing issue." | 26/07/2013 |
| Select | NICAS-608 | MDA-2013-056 | Protect-A-Line extension set. Manufactured by Vygon. | "Protect-A-Line extension set. Manufactured by Vygon. Product codes: 0832.01, 0832.04 and 0832.211. NHS Supply Chain codes (England only): FSB128, FSB124 and
FSB0146. Risk of false occlusion alarms and interruption to therapy. This is due to a new anti-syphon valve supplied with the sets, which has a higher opening pressure and may require adjustment of infusion pump occlusion alarm settings to avoid
false occlusion alarms. Vygon are validating a further modification to the anti-syphon valves to marginally reduce the
required opening pressure and will supply sets incorporating these once verification has been completed." | 25/07/2013 |
| Select | NICAS-609 | MDA-2013-057 | Spectra series powered wheelchairs. Manufactured by Invacare. Fitted with the Pilot+ digital wheelch | "Spectra series powered wheelchairs
Manufactured by Invacare. Fitted with the Pilot+ digital wheelchair control system supplied by PG Drives Technology. Potential for wheelchair components to
overheat in the event of a stall condition.
This can occur when the control system is
programmed with parameters different to those recommended by Invacare.
The manufacturer issued a Field Safety Notice (FSN), dated 14 May 2013, but has not had confirmation from a significant number of customers that they have received and acted upon this information." | 25/07/2013 |
| Select | NICAS-607 | MDA-2013-055 | Days walking stick. Model 404. Manufactured by Patterson Medical Ltd. Affected batch codes: HC1207, | "Days walking stick. Model 404.
Manufactured by Patterson Medical Ltd.
Affected batch codes: HC1207, HC1242 and HC1249. On specific batches of model 404 walking sticks the handle can crack and may cause the user to fall. Patterson Medical Ltd issued a Field Safety
Notice in June 2013 but has had insufficient
confirmation from users that they have acted on this information." | 24/07/2013 |
| Select | NICAS-606 | MDA-2013-054 | SLE - 4000-5000 Ventilator - Power Supply Unit | "SLE 4000/5000 ventilator.
Power supply unit (PSU) model FP110 – 410.
Specific serial numbers.
Potential component failure in the power supply unit (PSU). Failure of the PSU will cause the ventilator to alarm and shut down immediately." | 23/07/2013 |
| Select | NICAS-604 | MDA-2013-052 | Philips Healthcare - HeartStart MRx Monitor Defibrillator | "Philips Healthcare - HeartStart MRx Monitor Defibrillator.
Model numbers: M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6.
Affected serial numbers from US00100100 to US00565942 inclusive.
The Philips HeartStart MRx Monitor/Defibrillator may fail to deliver defibrillation therapy in either “Manual Defib”, “AED” or “Sync Cardioversion” mode." | 16/07/2013 |
| Select | NICAS-601 | MDA-2013-051 | Overhead and Mobile Patient Hoists: Standard Sling Bar 450 (Spreader bar). Specific models numbers. | "Overhead and Mobile Patient Hoists:
Standard Sling Bar 450 (Spreader bar).
Specific models numbers. Manufactured By Liko (A Hill-Rom Company). Risk of serious injury to a patient, caregiver or bystander could result from tripping or otherwise
falling on to the sling bar. The sling hook on the end of the sling bar could pierce a body structure such as the head, shoulder, or groin." | 09/07/2013 |
| Select | NICAS-599 | MDA-2013-049 | Ibis Comfort wheelchair. Manufactured by Handicare B.V. Specific serial numbers of chairs manufactur | "Ibis Comfort wheelchair. Manufactured by Handicare B.V. Specific serial numbers of chairs manufactured from 29 January to 12 April 2013 inclusive. Handicare has identified a quality issue with the
tilt adjustment on Ibis Comfort wheelchairs.
The upper hinge block component used in the tilt mechanism may break. This could cause the seat unit to tip backwards unexpectedly. There is a Field Safety Notice for UK Customers." | 04/07/2013 |
| Select | NICAS-600 | MDA-2013-050 | Urology: occlusion catheters, hydraulic ureter dilators and hydraulic urethral dilators.Manufactured | Urology: occlusion catheters, hydraulic ureter dilators and hydraulic urethral dilators.Manufactured by Teleflex Medical. Specific material/product and batch numbers.Packaging may be compromised and, therefore, the sterility of the product cannot be guaranteed, resulting in a risk of infection. | 04/07/2013 |
| Select | NICAS-598 | MDA-2013-048 | Update to MDA/2013/026. Recall of Hospira 1 litre suction canisters and liners - additional products | "Update to MDA/2013/026. Recall of Hospira 1 litre suction canisters and liners - additional products recalled. Suction canisters and liners with Abbott labels and
list numbers are now included in the recall.
1 litre suction canisters - Abbott list number
770462. 1 litre suction liners - Abbott list numbers L212A52 and L213A52.
Manufactured by Hospira (formerly manufactured by Abbott). All batch numbers are affected." | 02/07/2013 |
| Select | NICAS-597 | MDA-2013-047 | Safety blood collection and infusion sets. Various item and lot numbers. Manufactured by Greiner Bio | "Safety blood collection and infusion sets. Various item and lot numbers. Manufactured by Greiner Bio-One.
Risk of leakage of blood or infusion fluid, or
under-filling of evacuated blood collection tubes or blood culture bottles. This product is being recalled due to potential cracking of the Luer connector on these devices." | 27/06/2013 |
| Select | NICAS-596 | MDA-2013-046 | Needle-free IV access device: Double Octopus extension set with 2 Bionectors, anti-reflux valves and | "Needle-free IV access device: Double Octopus extension set with 2 Bionectors, anti-reflux valves and clamps Manufactured by Vygon. Product code: 0841233 NHS Supply Chain code: FSW388 Lot numbers: 021112AF, 081112AF and 091112AF. A moulding defect on the male Luer of the
Octopus may result in connection
difficulties and leakage between the
Octopus and other compatible devices
(e.g. a peripheral cannula). Risk of a delay in treatment or under-delivery of medication. The manufacturer issued a Field Safety Notice (FSN) in April 2013 recalling the three affected batches but they have received insufficient reconciliation data." | 25/06/2013 |
| Select | NICAS-593 | MDA-2013-043 | Rad-8 Pulse Oximeter with 20-pin patient cable connector. Manufactured by Masimo. Manufactured from | "Rad-8 Pulse Oximeter with 20-pin patient cable connector. Manufactured by Masimo. Manufactured from 27 March 2009 to 24 January 2013 inclusive. Specific serial numbers are affected. Risk of delay in treatment. Some Rad-8 pulse oximeters turn off when they are moved, without the operator pressing the power button. The manufacturer has issued a Field Safety
Notice (dated 08 March 2013) to each customer listing specific affected serial numbers." | 20/06/2013 |
| Select | NICAS-594 | MDA-2013-044 | Implantable screw: MatrixMANDIBLE, MatrixNEURO, MatrixMlDFACE and MatrixORTHOGNATHlCS. | Implantable screw- MatrixMANDIBLE, MatrixNEURO, MatrixMlDFACE and MatrixORTHOGNATHlCS. Manufactured by Synthes GmbH. Specific lot numbers affected. Recall due to incorrectly etched screw size on the screw-holding clip (see picture). The use of an incorrectly sized screw could lead to clinical complications including dural injury, bleeding and failure of fracture fixation. | 20/06/2013 |
| Select | NICAS-591 | MDA-2013-041 | Laboratory test kit - Intrinsic Factor Antibody test strips used in testing for vitamin B12 malabsor | "Laboratory test kit - Intrinsic Factor Antibody test strips used in testing for vitamin B12 malabsorption. Alegria Anti-Intrinsic Factor Assay (ORG-247-24) lot number 24723031 expiry 30/11/2013.
Manufactured by Orgentec Diagnostika GmbH distributed in the UK by Launch Diagnostics.Deterioration in the activity of affected lots may lead to false negative results outside of the manufacturer’s
claims for performance (61.2% sensitivity).
A false negative could result in a delay in diagnosis or treatment of vitamin B12 malabsorption. Laboratory internal quality control systems may not detect this deterioration. Orgentec issued a product notification letter in which they mention a further lot - 24723945 (expiry 28/02/2014). This lot has also shown a deterioration in activity in a recent UK NEQAS Haematinics distribution." | 19/06/2013 |
| Select | NICAS-590 | MDA-2013-040 | Laboratory test kit. Orgentec Alegria dsDNA IgG (ORG204G) for the diagnosis of lupus. Lot numbers: 2 | "Laboratory test kit. Orgentec Alegria dsDNA IgG (ORG204G) for the diagnosis of lupus. Lot numbers: 204G30204 and 204G30205. Manufactured by Orgentec Diagnostika GmbH, distributed in the UK
by Launch Diagnostics. An increase in sensitivity may lead to false positive results in tests for the diagnosis of
lupus. This issue may be related to the strip coating. Orgentec has sent a recall letter." | 17/06/2013 |
| Select | NICAS-589 | MDA-2013-039 | Workstation software for computed tomography systems | "Workstation software for computed tomography systems. Vitrea CT Brain Perfusion 2D application. Versions 6.0 and above for Vitrea Enterprise Suite, Vitrea, VitreaAdvanced and Vitrea fX are affected.
Manufactured by Vital Images, Inc. Risk of patient misdiagnosis, inappropriate
treatment or treatment delay due to
incompatibility of software with certain protocols or CT units. Analysis of data in Vitrea CT Brain Perfusion 2D may lead to inaccurate perfusion maps if the data is acquired by an unsupported CT scanner.
Vital Images has provided advice on the
systems that are and are not supported." | 13/06/2013 |
| Select | NICAS-588 | MDA-2013-038 | Rusch Belly Bag urine collection bag with hip belt. Specific product codes. Manufactured by Teleflex | "Rusch Belly Bag urine collection bag with hip belt. Specific product codes. Manufactured by Teleflex Medical. Packaging may be compromised and therefore the sterility of the product cannot be guaranteed. If non-sterile products are used, there is a risk
of infection." | 12/06/2013 |
| Select | NICAS-587 | MDA-2013-037 | SERVO-i ventilator system battery modules. Manufactured by Maquet. | "SERVO-i ventilator system battery modules.
Manufactured by Maquet. Part number 6487180. Product codes 1005-1243 (inclusive) and manufactured from 01/02/2010 to 25/10/2012. Risk of early or unexpected loss of ventilation due to certain battery modules having a shorter
than specified run time." | 03/06/2013 |
| Select | NICAS-586 | MDA-2013-036 | External pacemaker - MICRO-PACE REF 4580. Manufactured by Pace Medical and distributed in | "External pacemaker- MICRO-PACE REF 4580. Manufactured by Pace Medical and distributed in the UK by APC Cardiovascular. Update to MDA/2013/001 and MDA/2012/070 on the return to market of the MICRO-PACE
REF 4580." | 31/05/2013 |
| Select | NICAS-584 | MDA-2013-034 | RUSCH Macintosh laryngoscopes.Disposable laryngoscope metal kit, disposable laryngoscope battery han | "RUSCH Macintosh laryngoscopes. Disposable laryngoscope metal kit, disposable laryngoscope battery handles and reusable laryngoscope handles. There is potential for the light to flicker or fail during intubation due to a loose connection between the battery and the battery cap.
Manufactured by M.A. Arain & Brothers
(PVT) Ltd. Distributed in the UK by Teleflex (RUSCH). Specific lot numbers are affected.
There is potential for the light to flicker or fail during intubation due to a loose connection between the battery and the battery cap." | 15/05/2013 |
| Select | NICAS-579 | MDA-2013-029 | Reinforced endotracheal (ET) tubes | "Reinforced endotracheal (ET) tubes - Murphy, Magill, Murphy with stylet, Magill with stylet. Manufactured by Unomedical (a ConvaTec company). Available under three brand names - Unomedical UnoFlexTM,
EuromedicalTM TrachealFlexTM, PharmaPlast. Specific sizes and lots are affected. Potential for inadequate patient ventilation." | 10/05/2013 |
| Select | NICAS-580 | MDA-2013-030 | Single-use syringes - 50 ml Luer lock | "Single-use syringes - 50 ml Luer lock
Manufactured by Terumo Europe.
Product code BS-50LG (NHS Supply Chain code FWC245). Lot numbers 1208001, 1208002 and 1208003.Risk of delay or interruption to treatment when affected syringes are used in syringe pumps. Some syringes in the affected batches require a greater force than usual to push the plunger. This can lead to false occlusion alarms being triggered when they
are used in syringe pumps.
Terumo issued a Field Safety Notice (FSN)
in February 2013 recalling the three
batches affected by this manufacturing
problem." | 10/05/2013 |
| Select | NICAS-581 | MDA-2013-031 | Hospital beds - Dynamis and Gerialit with Dewert electrical control | "Hospital beds - Dynamis and Gerialit with Dewert electrical control systems. Manufactured by Hill-Rom. Specific models numbers manufactured from October 1995 to June 2001 inclusive. Risk of serious injury to patients, staff and visitors.
Unintentional movement, including sudden
collapse to its lowest position, can occur when the bed is connected to the mains supply. A Field Safety Notice (FSN) was published on 01 March 2012. However, the manufacturer has since advised that these beds should be fixed to their lowest position and the control system deactivated to remove the risk of injury." | 10/05/2013 |
| Select | NICAS-583 | MDA-2013-033 | Diacap Ultra dialysis fluid filter. Manufactured by B. Braun Avitum AG. | "Diacap Ultra dialysis fluid filter. Manufactured by B. Braun Avitum AG.
Product code: 7107366. All devices that are more than 10 months from
the date of manufacture are affected. Risk of a gradual increased fluid removal, which
may cause symptoms of hypotension during
dialysis treatment. Ultrafiltration deviations may not be immediately detected by the machine. This is due to a decrease in the residual moisture of the filter membrane, which can cause a higher fluid removal from the patient than initially selected." | 10/05/2013 |
| Select | NICAS-575 | MDA-2013-025 | Home use blood glucose meter: FreeStyle InsuLinx manufactured by Abbott Diabetes Care. | "Home use blood glucose meter: FreeStyle InsuLinx manufactured by Abbott
Diabetes Care. At extremely high blood glucose levels of 56.8 mmol/l and above, the meter will display and store in its memory an incorrect low test result.
An incorrect low result may delay a diagnosis of diabetic ketoacidosis and suggest an incorrect insulin dose." | 01/05/2013 |
| Select | NICAS-576 | MDA-2013-026 | Suction canisters and liners. All Receptal: 1 litre canisters (List number 43449), 1 litre PVC liner | "Suction canisters and liners. All Receptal:
1 litre canisters (List number 43449),
1 litre PVC liners (List number OL212)
and 1litre PE liners (List number OL213).
Manufactured by Hospira (formerly
manufactured by Abbott). All batch numbers are affected. Potential failure or loss of suction. Due to a number of customer complaints, Hospira has issued a Field Safety Notice (dated 12 April 2013) to recall all 1 litre devices and instruct customers to seek alternatives. The MHRA is not confident that Hospira has sufficient alternative stock available to supply the demand during a recall." | 01/05/2013 |
| Select | NICAS-577 | MDA-2013-027 | Baxter Healthcare Ltd - Peritoneal dialysis transfer sets | "Baxter Healthcare Ltd - Peritoneal dialysis transfer sets.
Product Codes R5C4325, R5C4326, 5C4482, R5C4483 and R5C4484.
All Batches" | 01/05/2013 |
| Select | NICAS-574 | MDA-2013-024 | Single use syringes: PlastipakTM 50ml Luer Lok Manufactured by BD Medical. Product codes affected: 3 | "Single use syringes: PlastipakTM 50ml Luer Lok Manufactured by BD Medical. Product codes affected: 300223 non sterile, 300865 sterile (NHS Supply Chain code FWC034), 300869 Amber – sterile.
Specific lot numbers are affected.
Risk of delay or interruption to treatment when affected syringes are used in power-driven syringe pumps. A change to the design of the syringe plunger in April 2012 may have required syringe pump occlusion alarm
settings to be adjusted to avoid false occlusion alarms. Use of older design syringes in pumps that have been
adjusted can result in a delay to the occlusion alarm being triggered. BD is now recalling syringes of the old design to avoid this risk." | 25/04/2013 |
| Select | NICAS-573 | MDA-2013-023 | Workstation software for computed tomography systems: Vitrea Enterprise Suite, Vitrea, VitreaAdvance | "Workstation software for computed tomography systems: Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore
(VitalConnect) and Vitrea fX, all versions prior to version 6.3.3. Manufactured by Vital Images, Inc. Risk of measurement error when images are rotated at the time of reconstruction. There is the potential for volume errors of -50% and length errors of -29%, depending on the degree to which the images are rotated." | 12/04/2013 |
| Select | NICAS-572 | MDA-2013-022 | Home use blood glucose meters:Lifescan OneTouch Verio Pro;Lifescan OneTouch Verio IQ | "Home use blood glucose meters:Lifescan OneTouch Verio Pro;Lifescan OneTouch Verio IQ. Recall of One Touch Verio meters because of a software fault at glucose levels of 56.8mmol/land above.
One Touch Verio Pro: At very high blood
glucose concentrations a falsely low result will be displayed.
One Touch Verio IQ: At very high blood
glucose concentrations no result will be
displayed." | 11/04/2013 |
| Select | NICAS-571 | MDA-2013-021 | Intraocular lens one-piece foldable posterior chamber - HOYA Surgical Optics | "Intraocular lens one-piece foldable posterior chamber - HOYA Surgical Optics.
Model numbers:
iSert® 250, iSert® 251, iSert® Toric 351 and iSert® Toric 311.
Specific serial numbers.
Higher than expected rates of inflammation and/or endophthalmitis observed following implantation of affected intraocular lenses." | 03/04/2013 |
| Select | NICAS-570 | MDA-2013-020 | Acrobat Swing arm manufactured by Ondal | "Acrobat Swing (AC Swing) arm. Manufactured by Ondal.
Supplied by various companies to support operating lights and monitors.
Delivered from 1999 to 2008 inclusive.
Risk of injury from detachment of the swing arm." | 27/03/2013 |
| Select | NICAS-566 | MDA-2013-017 | Alaris GP volumetric pump | "Infusion pump: Alaris® GP volumetric pump
Product refs: 80063UN01, 80263UN01, 80263UN01-G, 9002MED01, 9002MED01-G
Manufactured by CareFusion.
All serial numbers are affected.
Risk of embolism.
The pump produces small air bubbles (less than 50µl) which are too small to trigger either the 50-500µl air-in-line alarm set by the user, or the 1ml over a rolling 15 minutes alarm." | 26/03/2013 |
| Select | NICAS-567 | MDA-2013-018 | Aquarius haemofiltration machine | "Aquarius haemofiltration machine using software version 6.01.
Supplied and supported by Baxter Healthcare Ltd.
Manufactured by Edwards Lifesciences Ltd
(now Nikkiso Europe GmbH).
Revised software version 6.02.07 to replace software version 6.01, has now been released for implementation. Baxter Healthcare Ltd will be managing the software rollout." | 26/03/2013 |
| Select | NICAS-564 | MDA-2013-015 | Gas pressurised spray devices for application of sprayable fibrin sealants used for intra-operative | "Gas pressurised spray devices for application of sprayable fibrin sealants used for intra-operative haemostasis.The risk of life-threatening/fatal gas or air
embolism.This appears to be related to the use of spray devices to apply fibrin sealants when: the pressure setting is greater than recommended, or
when the device is held closer to the
tissue surface than is recommended by
the manufacturer, or
when the appropriate gas for spraying
under pressure is not used.
A European wide review on the safety of theseproducts has now been completed. Updatedadvice to healthcare professionals has beenissued in relation to maximum pressure, minimum distance, and type of gas to use for the spray application of fibrin sealants authorised for use in the UK.
Details are provided in Drug Safety Update
volume 6 Issue 7 February 2013 and in the
information provided to users by the
manufacturers of the spray device, and with the fibrin sealants and their delivery devices." | 21/03/2013 |
| Select | NICAS-563 | MDA-2013-014 | Oxoid antimicrobial susceptibility testing discs (AST) manufactured by Thermofisher Scientific. | "Oxoid antimicrobial susceptibility testing
discs (AST) manufactured by Thermofisher Scientific.The manufacturer has issued nine Field Safety Notices since November 2011 recalling batches of AST disc, due to the presence of nonimpregnated or ‘blank’ AST discs manufactured before December 2012. AST discs may, therefore, not perform to the expected specification.
Blank discs could lead to a false indication of antibiotic resistance, which in turn could lead to delayed reporting, reduced options for treatment or unnecessary changes to treatment." | 20/03/2013 |
| Select | NICAS-560 | MDA-2013-011 | Endoscopic tissue remover: VersaCut Morcellator control box model: 0636-470-01 | "Endoscopic tissue remover: VersaCut Morcellator control box model: 0636-470-01
Manufactured by Lumenis Ltd All devices manufactured since May 1998. Risk of air embolism if the tubing from the
handpiece to the aspiration pump is connected incorrectly. Lumenis Ltd issued a Field Safety Notice (FSN) dated 02 January 2013 but has not received
sufficient confirmation from users that they have received and acted on this information." | 19/03/2013 |
| Select | NICAS-561 | MDA-2013-012 | Diagnostic test strips and cassettes for urinalysis, pregnancy testing, menopause testing and opiate | "Diagnostic test strips and cassettes for urinalysis, pregnancy testing,
menopause testing and opiates testing, manufactured by: IND Diagnostics Inc, Canada, Alere International Ltd, Barrier Healthcare Ltd and E-Pharm Ltd. Health Canada (the Canadian regulatory authority for medical devices) has suspended sale of these kits in Canada due to concerns about the manufacturer’s quality systems – see: http://healthycanadians.gc.ca/recall-alert-rappelavis/hc-sc/2013/23151a-eng.php" | 19/03/2013 |
| Select | NICAS-562 | MDA-2013-013 | Mitral Valve Repair System. MitraClip Clip Delivery System. Manufactured by Abbott | "Mitral Valve Repair System. MitraClip Clip Delivery System. Manufactured by Abbott
Vascular. Risk of death or serious harm to the patient. If the Actuator Knob on the Clip Delivery System (CDS) is turned in the wrong direction, this can prevent successful deployment of the clip, leading to the need for open surgical repair." | 19/03/2013 |
| Select | NICAS-558 | MDA-2013-009 | Vygon - Nasogastric feeding tubes | "Vygon - Nasogastric feeding tubes - Ryles tubes (weighted tip).
Size 12FG 125cm, product code: 392.12,
lot number: 160412FG.
Size 14FG 125cm, product code: 392.14,
lot number: 100512FF.
Risk of incorrect placement of the feeding tube due to incorrectly applied depth markings." | 26/02/2013 |
| Select | NICAS-557 | MDA-2013-008 | Electrosurgery disposable active electrodes and accessories. Manufactured by ConMed Corporation. Spe | "Electrosurgery disposable active electrodes and accessories.
Manufactured by ConMed Corporation.
Specific catalogue numbers and lot codes.
Potential risk of intra-operative infection from a breach in the sterile packaging.
The packaging breach may not be easily seen by the user, especially if the electrode does notprotrude from the package. ConMed is recalling affected devices." | 21/02/2013 |
| Select | NICAS-554 | MDA-2013-005 | Laboratory analysers for a variety of tests including HIV, tumour markers and hepatitis. Specific a | "Laboratory analysers for a variety of tests including HIV, tumour markers and hepatitis. Specific assays.
ADVIA Centaur and ADVIA Centaur XP, manufactured by Siemens Healthcare Diagnostics Inc. Specific catalogue numbers.
A failure of the wash interconnect circuit board on the ADVIA Centaur and ADVIA Centaur XP analysers may produce the following errors:
1. Failure to detect that the ‘Wash 1’ bottle is empty. This could result in credible but
erroneous results reported on a number of
tests. See affected assays listed below.
Or 2. Incorrect indication that the ‘Wash 1’ bottle is empty, causing the system to stop processing samples. Siemens is planning software and hardware updates to resolve these issues by the end of March 2013." | 15/02/2013 |
| Select | NICAS-553 | MDA-2013-004 | Infusion pumps: Plum A+ single channel infuser systems. Manufactured by Hospira.Product codes: 11005 | "Infusion pumps: Plum A+ single channel
infuser systems. Manufactured by Hospira. Product codes: 11005, 11971, 12391, 20792.
Risk of interruption in therapy due to clinical
staff failing to hear the alarm. The operation of the alarm volume control is not
consistent with the operator’s manual. On some pumps, the knob is turned clockwise to increase the volume, on others, it is anticlockwise. Hospira will be updating the user manual and providing labels for each device to identify the correct operating direction." | 06/02/2013 |
| Select | NICAS-551 | MDA-2013-003 | Ambulatory insulin infusion pumps. Manufactured by Animas. Animas IR1200, Animas IR1250 and Animas 2 | "Ambulatory insulin infusion pumps. Manufactured by Animas. Animas IR1200, Animas IR1250 and Animas 2020. All serial numbers. The pumps will only operate until 31 December 2015 due to a software problem. From 01 January 2016 the pumps will not deliver insulin and will generate a call service alarm. The manufacturer has stated that this software issue will not affect pumps prior to 01 January 2016.
Further information is available in the
manufacturer’s Field Safety Notice (FSN) dated 12 November 2012." | 22/01/2013 |
| Select | NICAS-549 | MDA-2013-002 | Medical oxygen and medical air cylinders filled to 200 atmospheres (200 bar/20,000 kPa). Various siz | "Medical oxygen and medical air cylinders filled to 200 atmospheres (200 bar/20,000 kPa). Various sizes and outlets. Supplied by SOL SpA. Risk of serious injury to staff and patients. Currently 137 bar cylinders are widely used in the UK. Connection to significantly higher pressure 200 bar cylinders may cause damage to devices such as anaesthetic machines, ventilators,
incubators, respiratory support and
resuscitation equipment." | 14/01/2013 |
| Select | NICAS-548 | MDA-2013-001 | External pacemaker: MICRO-PACE REF 4580. Manufactured by Pace Medical and distributed in the UK by A | External pacemaker: MICRO-PACE REF 4580. Manufactured by Pace Medical and distributed in the UK by APC Cardiovascular. Further to MDA/2012/070 addressing the potential for loss of ventricular output or sensing failure, Pace Medical Inc has temporarily withdrawn the MICRO-PACE REF 4580 from sale. | 10/01/2013 |
| Select | NICAS-547 | MDA-2012-083 | Laboratory analyser. Mass spectrometers manufactured by Waters Corporation, a US corporation. Specif | "Laboratory analyser. Mass spectrometers manufactured by Waters Corporation, a US corporation. Specific products. The ion block source heater can fail, potentially
leading to inaccurate results which may not be picked up by quality control or internal standard monitoring.
Assays with shorter dwell times are most
affected, including neonatal screening for
phenylketonuria, medium chain acyl CoA
dehydrogenase deficiency and maple syrup
urine disease." | 12/12/2012 |
| Select | NICAS-546 | MDA-2012-082 | Walking frames. Model: Coopers. Product codes: 7321C, 7323C, 7325C, 7331C, 7333C, 7335C, 7341C, 7343 | "Walking frames.Model: Coopers.
Product codes: 7321C, 7323C, 7325C, 7331C, 7333C, 7335C, 7341C,
7343C, 7351C, 7353C. Despatch dates from 20 August to 02 October 2012 inclusive. Manufactured by Sunrise Medical. Risk of falls due to the walking frame becoming unstable. The rear screws that fasten the C-shaped lower bar to the frame may fail because of a manufacturing fault. The failure usually occurs a short time after assembly." | 06/12/2012 |
| Select | NICAS-545 | MDA-2012-081 | Workstation software for computed tomography systems: Vitrea fX, Vitrea and Vitrea Enterprise Suite. | Workstation software for computed tomography systems: Vitrea fX, Vitrea and Vitrea Enterprise Suite. Manufactured by Vital Images. Various software versions are affected. Risk of misdiagnosis and treatment of vessels due to incorrect calcium scores. There is the potential for errors in calcium score values in restored snapshots of studies generated through use of these devices. If these calcium scores are relied upon, less–healthy vessels may be incorrectly considered as healthy, which may lead to incorrect or sub optimal treatment paths being followed. | 29/11/2012 |
| Select | NICAS-543 | MDA-2012-080 | Chest drain unit: Pleuraseal III chest drainage bottle. Manufactured by Rocket Medical. Product code | Chest drain unit: Pleuraseal III chest drainage bottle. Manufactured by Rocket Medical. Product codes: R54543 and R54545. Specific lot numbers are affected. Risk of pneumothorax. As a result of a manufacturing problem, the seal may be breached, or the tubing can become occluded. The affected products are being recalled. The manufacturer published a Field Safety Notice (FSN) in September 2012 to notify users and prompt them to take action. The manufacturer has not received sufficient confirmation that this FSN has been received and acted upon. | 22/11/2012 |
| Select | NICAS-542 | MDA-2012-079 | Samaritan public access defibrillator PAD300-PAD300P | "Samaritan public access defibrillator PAD300-PAD300P. Manufactured by HeartSine Technologies Ltd.
Risk of failure to deliver therapy caused by two different faults:
1. Some defibrillators may repeatedly turn on and off when not in use, leading to unexpected battery depletion.
2. Defibrillators with early versions of the battery management software may switch off after delivering a single shock or give a premature low battery warning." | 20/11/2012 |
| Select | NICAS-541 | MDA-2012-078 | X-ray detectable gauze swabs. Multi-X 10 cm x 7.5 cm 32 ply. Cat no:82410/S2005 Lot: 12401406 Manufa | X-ray detectable gauze swabs. Multi-X 10 cm x 7.5 cm 32 ply. Cat no:82410/S2005 Lot: 12401406 Manufactured by Frontier Multigate. The X-ray detectable thread may shred during use due to excessive irradiation during manufacturing. If a swab without the X-ray thread present is left inside the patient, it will not be detectable by X-ray examination. Any material shed from the gauze swabs, although not toxicologically harmful, may cause inflammation and potentially also granulation of tissue. | 09/11/2012 |
| Select | NICAS-539 | MDA-2012-076 | Wound dressing. Systagenix INADINE® PVP-I non adherent dressing (9.5cm x 9.5 cm). Manufactured by Sy | "Wound dressing. Systagenix INADINE® PVP-I non adherent dressing (9.5cm x 9.5 cm). Manufactured by Systagenix Wound
Management. Product code: P01491. Lot numbers: 1227/1228/1229. Compromised sterility with possible increased
risk of infection. The manufacturer issued a Field Safety Notice (FSN) for this device on 30 August 2012. A copy of the FSN is in the appendix of this alert, and it is also available on the MHRA website. This alert has been issued in support of the manufacturer’s actions." | 08/11/2012 |
| Select | NICAS-540 | MDA-2012-077 | Batteries for HeartStart XL defibrillator/monitor. Battery part number M3516A. Batch labelled ‘Made | "Batteries for HeartStart XL defibrillator/monitor. Battery part number M3516A. Batch labelled ‘Made in Taiwan’ with ‘Date of Manufacture’ code ‘R-2011-12’. Manufactured by Philips and distributed by Philips and Cardiac
Services UK & Ireland." | 08/11/2012 |
| Select | NICAS-537 | MDA-2012-074 | Electrosurgery grounding pads: DGP-HP RFA High-Power single use grounding pad and Cool-Tip RFA Elect | "Electrosurgery grounding pads: DGP-HP
RFA High-Power single use grounding
pad and Cool-Tip RFA Electrode Kits
(containing DGP-HP RFA single use
grounding pads). Manufactured by Covidien.
Risk of burns to the patient at the pad site.
As a result of contamination, the foil on the
grounding pad may degrade. This can result in an electrical disconnection, possibly leading to overheating." | 24/10/2012 |
| Select | NICAS-536 | MDA-2012-073 | Embolectomy, biliary and irrigation catheters. Distributed by Applied Medical. Bard® thrombectomy an | "Embolectomy, biliary and irrigation catheters. Distributed by Applied Medical.
Bard® thrombectomy and Bard® biliary and cholangiography catheters. Distributed by Bard Limited. Specific lot numbers. The manufacturer has identified a problem with
plastic particles being observed within the
catheter packaging. These plastic particles could become attached to the catheter and be transferred to the patient." | 22/10/2012 |
| Select | NICAS-535 | MDA-2012-072 | AlboGraft polyester vascular graft. Manufactured by LeMaitre. All lots. | "AlboGraft polyester vascular graft.
Manufactured by LeMaitre. All lots. In June 2012 the MHRA lifted the prohibition on
the sale of AlboGraft polyester vascular graftsand withdrew MDA/2012/018.
However, the advice given in MDA/2012/010 – that these grafts should be leak tested prior to use – continues to apply until the end of December 2012." | 18/10/2012 |
| Select | NICAS-534 | MDA-2012-071 | Urine analysis reagent strips for professional use only. 10LG Parameter urine reagent strips manufac | Urine analysis reagent strips for professional use only. 10LG Parameter urine reagent strips manufactured by IND Diagnostic Inc, Canada. Distributed in the UK by HomeHealth UK. Catalogue number series: 900 - 01 to 900 -11. The ‘use-by’ date (once seal is broken) of these products has been reduced from 90 days to 30 days. Products manufactured after September 2012 have new labels and instructions for use. Test strips from bottles opened for more than 30 days may give false positive or false negative results for certain parameters. | 17/10/2012 |
| Select | NICAS-532 | MDA-2012-069 | Intravenous (IV) connectors: one-way valves (examples are: non-return, check, anti-reflux or anti-si | "Intravenous (IV) connectors: one-way valves (examples are: non-return, check, anti-reflux or anti-siphon/anti free-flow
valves). All manufacturers and brands." | 09/10/2012 |
| Select | NICAS-533 | MDA-2012-070 | Pace Medical - External pacemaker used with temporary endocardial pacing leads or epicardial pacing | "Pace Medical - External pacemaker used with temporary endocardial pacing leads or epicardial pacing wires.
MICRO-PACE 4580.
Manufactured by Pace Medical and distributed in the UK by APC Cardiovascular." | 09/10/2012 |
| Select | NICAS-531 | MDA-2012-068 | Teleflex - ConchaTherm Neptune heated humidifiers | "Teleflex - ConchaTherm Neptune heated humidifiers.
Product codes: 425–00, 425–10 and 425–30.
Potential for failure of the speaker. If the speaker fails, no alarm will sound in the event of a device failure, which could cause a delay in patient treatment." | 25/09/2012 |
| Select | NICAS-530 | MDA-2012-067 | Pegasus UltraLo low height electric bed. | "Pegasus ‘UltraLo’ low height electric bed. Manufactured by Pegasus and ArjoHuntleigh from 2005 to 2011 inclusive. Model 9050, all serial numbers.
The manufacturer has introduced limitations
affecting the use of this bed and has revised the instructions for use. These changes alter how the bed can be used in hospitals.
A Field Safety Notice (FSN) was published on 19 June 2012, but the manufacturer has not had sufficient confirmation from users that they have received and acted on this information." | 20/09/2012 |
| Select | NICAS-529 | MDA-2012-066 | ShileyTM reusable cannula cuffed tracheostomy tubes. | "ShileyTM reusable cannula cuffed
tracheostomy tubes. Product numbers 8FEN and 8LPC. Various lots. Manufactured by Covidien. Various distributors.
There have been reports of leakage and
disconnection between the inner and outer
cannulae, which may compromise patient
ventilation.
Covidien issued a Field Safety Notice (FSN) on 23 July 2012 (see appendix) to recall affected devices. However, the MHRA cannot be confident that the recall action has been effective and that users have received and acted on the information." | 19/09/2012 |
| Select | NICAS-528 | MDA-2012-065 | Endoscope washer disinfectors (EWD) fitted with channel separator LFC-S-05 manufactured by Getinge L | "Endoscope washer disinfectors (EWD) fitted with channel separator LFC-S-05 manufactured by Getinge Lancer, when used with Fujinon G5 endoscopes. All models of EWD are affected. Risk of inadequate endoscope decontamination,
when using a LFC-S-05 channel separator." | 13/09/2012 |
| Select | NICAS-525 | MDA-2012-063 | Arcomed - Infusion Pump | "Infusion pumps:
Volumed VP7000 Premium, Volumed VP7000 Classic Plus and
Volumed VP7000 Lite.
Syramed ?SP6000 Premium and Syramed SP6000 Classic Plus.
Specific serial numbers are affected.
Manufactured by Arcomed AG.
Risk of delay in infusion therapy." | 12/09/2012 |
| Select | NICAS-526 | MDA-2012-064 | Surgical Stapler. Duet TRS Universal Straight and articlating single use loading units. Manufactured | "Surgical stapler. Duet TRSTM Universal straight and articulating single use loading units (SULU). These devices may also have
been incorporated into BEST PRACTICETM kits. Manufactured by Covidien. These tissue-reinforced stapler loading units
have the potential to injure adjacent anatomical structures within the thorax and abdomen, which may result in life-threatening post-operative complications." | 12/09/2012 |
| Select | NICAS-523 | MDA-2012-061 | Implantable cardioverter defibrillator (ICD) leads Riata and Riata ST by St Jude Medical | "Implantable cardioverter defibrillator (ICD) leads Riata and Riata ST by St Jude Medical.
Risk of inappropriate shock or therapy failure due to wear of lead insulation after implantation." | 10/09/2012 |
| Select | NICAS-521 | MDA-2012-059 | Animas ambulatory insulin infusion. Animas® IR 1200 Animas® 2020 One Touch® Ping® Glucose management | "Animas ambulatory insulin infusion pumps. Animas® IR 1200 Animas® 2020 One Touch® Ping® Glucose management system Animas® Vibe™. Risk of compromised insulin therapy due to
failure of the buttons caused by keypad wear." | 22/08/2012 |
| Select | NICAS-522 | MDA-2012-060 | Powered wheelchairs. All chairs in the Harrier range. Manufactured by Invacare. | "Powered wheelchairs. All chairs in the Harrier range. Manufactured by Invacare. The drive wheel may detach from the
wheelchair, as a result of being incorrectly
refitted due to inadequate service/maintenance instructions in the technical manual.
The manufacturer published a Field Safety
Notice (FSN) in April 2012 to notify technicians of the revised removal / refitting procedure. The manufacturer has not received sufficient confirmation that this FSN had been received and acted upon." | 22/08/2012 |
| Select | NICAS-520 | MDA-2012-058 | Sterile water for irrigation - manufactured by Baxter Healthcare Ltd | "Sterile water for irrigation 1000ml.
Manufactured by Baxter Healthcare Ltd.
Product code: UKF7114.
Lot nos: 12D10B26 and 12D10B26A.
Supplied from 1 May 2012 to 22 May 2012 inclusive.
Risk of contamination of these lots." | 21/08/2012 |
| Select | NICAS-519 | MDA-2012-057 | Sterile Water for Irrigation 1000ml. Manufactured by Baxter Healthcare Ltd. Product code: UKF7114. L | "Sterile Water for Irrigation 1000ml. Manufactured by Baxter Healthcare Ltd. Product code: UKF7114. Lot no: 12D10B26.
Risk of contamination of this batch. There has been a report in France that bottles within this batch were contaminated with Aspergillus.
This is still under investigation and the affected batch is being independently tested. In the meantime precautionary measures are being taken." | 17/08/2012 |
| Select | NICAS-518 | MDA-2012-056 | Orthopaedic pins, bone drill bits, taps and trocars manufactured by Smith & Nephew Orthopaedics Ltd. | "Orthopaedic pins, bone drill bits, taps and trocars manufactured by Smith & Nephew Orthopaedics Ltd. Specific lots/batches. Potential risk of intra-operative infection from a breach in the sterile packaging.
Smith & Nephew Orthopaedics Ltd issued a
Field Safety Notice in June 2012 recalling
affected devices." | 16/08/2012 |
| Select | NICAS-517 | MDA-2012-055 | neria steel cannula infusion sets manufactured by Unomedical. Specific product references | "neria steel cannula infusion sets manufactured by Unomedical. Specific product references. Risk of needle breaking in use leading to leakage of medication, and the potential need
for surgical intervention to remove needle.
The manufacturer issued a Field Safety Notice in June 2012, but has not had confirmation from all users that they have received and acted on this information." | 08/08/2012 |
| Select | NICAS-516 | MDA-2012-054 | SpeediCath Complete intermittent urinary drainage catheters. | "SpeediCath Complete intermittent urinary
drainage catheters. Manufactured by Coloplast. Multiple product codes and lot numbers. Coloplast has recalled these products as the sterility of the catheters may be compromised. Coloplast issued a Field Safety Notice (FSN) (see appendix) about this recall on 5 June 2012.
However, the MHRA cannot be confident that the recall action has been effective and that users have received and acted on the information. These products will not be available until Coloplast has identified the root cause of the failure and implemented corrective actions." | 06/08/2012 |
| Select | NICAS-515 | MDA-2012-053 | Products used as endoscope accessory holders. All manufacturers. | "Products used as endoscope accessory holders. All manufacturers. Inappropriate use of accessory holders within endoscope washer disinfectors (EWD) may lead to contamination of devices, equipment and processing media by retained soil and material from the endoscope accessory holder.
Products that are not specified as suitable for decontamination within the EWD can be as problematic as products that are not designed as endoscope accessory holders." | 03/08/2012 |
| Select | NICAS-514 | MDA-2012-052 | Home use blood glucose monitoring system for visually impaired patients. Clever Chek TD4232 talking | "Home use blood glucose monitoring
system for visually impaired patients.
Clever Chek TD4232 talking blood glucose meter and test strips. Distributed in the UK by BBI Healthcare. This meter does not alert users when insufficient blood has been applied to the test strip, giving the potential for false results, and resultant inappropriate insulin administration.
The distributor has now stopped distributing the meter and test strips in the UK. Please see the Field Safety Notice (dated 20 July 2012) for further information." | 02/08/2012 |
| Select | NICAS-513 | MDA-2012-051 | Bionector S needle-free intravenous connectors - manufactured by Vygon | "Bionector S needle-free intravenous connectors - manufactured by Vygon.
Risk of delay in the administration of emergency medicines during the resuscitation of patients, as some pre-filled glass syringes are no longer compatible with the Bionector S, unless an adaptor is used." | 26/07/2012 |
| Select | NICAS-512 | MDA-2012-050 | Tourniquet Six-use tourniquet cuff – all sizes Manufactured by Anatic Aid | "Tourniquet Six-use tourniquet cuff – all sizes Manufactured by Anatic Aid.
Batch number 15435.
Risk of excessive bleeding, as inlet tube may disconnect from the main body of the tourniquet during use." | 24/07/2012 |
| Select | NICAS-511 | MDA-2012-049 | Neonatal and paediatric endotracheal tube clamp - holder manufacturered by EMS Medical | "Neonatal and paediatric endotracheal tube clamp - holder manufacturered by EMS Medical.
Risk of airway loss due to slippage of the clamp/holder." | 23/07/2012 |
| Select | NICAS-510 | MDA-2012-048 | Central venous and haemodialysis catheters manufactured by Arrow Int | "Central venous and haemodialysis catheters - various Arrowg+ard Blue and Arrowg+ard Blue Plus.
Manufactured by Arrow International (a division of Teleflex)." | 20/07/2012 |
| Select | NICAS-509 | MDA-2012-047 | Total ankle replacement implants - Ankle Evolutive System (AES). Manufactured by Transystème (all lo | Total ankle replacement implants - Ankle Evolutive System (AES). Manufactured by Transystème (all lots). Higher than expected frequency of osteolytic lesions for patients implanted with AES total ankle replacement implants. | 18/07/2012 |
| Select | NICAS-504 | MDA-2012-042 | FRED easy Defibrillators manufactured by Schiller | "FRED easy Defibrillators manufactured by Schiller. All devices are affected. Devices are distributed by Amazon Medical Ltd. A false defibrillator error message, ""transistor
error"", displays on screen and requires the
device to be re-started. This problem may prevent shock delivery, which may result in failure to defibrillate and a reduced chance of survival for the patient." | 16/07/2012 |
| Select | NICAS-505 | MDA-2012-043 | Schiller electrodes: silver packet, manufactured by Nessler Medizintechnik. | "Schiller electrodes: silver packet, manufactured by Nessler Medizintechnik.
All (Paediatric and Adult) electrodes are affected. Distributed by Amazon Medical
Ltd. Premature drying up of electrodes due to a manufacturing quality problem.
This may prevent shock delivery, which may
result in failure to defibrillate and a reduced
chance of survival for the patient." | 16/07/2012 |
| Select | NICAS-506 | MDA-2012-044 | Legendair and Supportair Portable Ventilators. | "Legendair and Supportair Portable
Ventilators. Specific ventilator codes (see FSN). Manufactured by Airox. Supplied by Airox and Covidien. Potential for the ventilator’s internal battery to fail. This can result in non-ventilation of the patient.
This is due to failure of a capacitor (C53) on
the printed circuit board (PCB). The ventilator will still function on external
battery power and mains power." | 16/07/2012 |
| Select | NICAS-507 | MDA-2012-045 | Aquarius haemofiltration machine consumables. BM25 haemofiltration machine consumables. Specific cod | "Aquarius haemofiltration machine consumables. BM25 haemofiltration machine consumables. Specific codes are affected (see Appendices). All consumables are supplied by Baxter Healthcare Ltd. Baxter cannot guarantee the supply of
haemofiltration machine consumables, as
earthquakes in Italy have severely affected
the manufacturing facilities. A lack of consumables could restrict the provision of Continuous Renal Replacement Therapy and Therapeutic Plasma Exchange." | 16/07/2012 |
| Select | NICAS-508 | MDA-2012-046 | Non CE-marked portable dental X-ray units. Including the Tianjie Dental ‘Falcon’. | "Non CE-marked portable dental X-ray units.
Including the Tianjie Dental ‘Falcon’. Testing by the Health Protection Agency (HPA) has revealed that the Tianjie Dental Falcon device lacks sufficient shielding in the X-ray tube, which could give rise to high patient doses and under typical high radiographic workloads result in operator doses in excess of the Ionising Radiation Regulations 1999 annual dose limits. This could give rise to adverse health effects caused by radiation." | 16/07/2012 |
| Select | NICAS-502 | MDA-2012-040 | Standing aids: Encore, Chorus and Sara Plus. All models. Manufactured by ArjoHuntleigh. | Standing aids: Encore, Chorus and Sara Plus. All models. Manufactured by ArjoHuntleigh. Risk of impalement and severe trauma when a support bracket is left exposed, contrary to the manufacturer’s instructions. | 10/07/2012 |
| Select | NICAS-503 | MDA-2012-041 | Ethicon Endo-Surgery (EES). Counterfeit Ligaclip® Extra Ligating Clip Cartridges (Product Code LT300 | "Ethicon Endo-Surgery (EES). Counterfeit Ligaclip® Extra Ligating Clip Cartridges
(Product Code LT300). Counterfeit Ligaclip® Extra Ligating Clip Cartridges may have been supplied to UK
hospitals via unauthorised distributors.
Ethicon Endo-Surgery, the legitimate
manufacturer, cannot guarantee the safety of these counterfeit clips." | 10/07/2012 |
| Select | NICAS-501 | MDA-2012-039 | Pump or gravity blood administration set used in conjunction with Flogard and Colleague infusion pum | "Pump/gravity blood administration set used in conjunction with Flogard and Colleague infusion pumps. Product reference: VMC9609. Lot number: 11K21V628. Manufactured by Baxter Healthcare.
Due to a manufacturing error the blue slide clamp may have been incorrectly assembled.
If a faulty set is successfully inserted into a pump, blood may be drawn from, instead of infused into, the patient.
There is no risk to patients if the set is used for gravity infusion." | 03/07/2012 |
| Select | NICAS-500 | MDA-2012-037 | Mobile patient hoist carabiners | "Mobile patient hoist carabiners. All Birdie and Flamingo mobile patient hoist carabiners. Manufactured by Invacare.
Scheduled inspections have failed to identify excessive wear of these aluminium carabiners, which can unexpectedly break and detach from the spreader bar. This can result in a patient falling from the hoist." | 02/07/2012 |
| Select | NICAS-497 | MDA-2012-035 | Metal-on-metal (MoM) hip replacements: Metal liner component of the R3 acetabular system manufacture | "Metal-on-metal (MoM) hip replacements:
Metal liner component of the R3 acetabular system manufactured by Smith & Nephew Orthopaedics Ltd. Increased rates of revision of MoM hip replacements when using the metal liner component of the R3 acetabular system." | 25/06/2012 |
| Select | NICAS-496 | MDA-2012-034 | Endoscope washer-disinfector (EWD) manufactured by Wassenburg Medical Devices B.V. when used with Tr | Endoscope washer-disinfector (EWD) manufactured by Wassenburg Medical Devices B.V. when used with Tristel One-Shot disinfectant (TOS440). Models WD440 & WD440PT. The disinfectant sensing probe may fail to detect disinfectant levels correctly leading to inadequate decontamination of endoscopes. | 19/06/2012 |
| Select | NICAS-495 | MDA-2012-033 | Hudson RCI BiteGard | "Hudson RCI BiteGard - Part numbers 1140 and 41140 - Manufactured by Teleflex.
Distributed by the manufacturer and third party suppliers.
Risk of airway blockage or choking as the bite block can separate from the handle. The bite block can migrate into the oesophagus or trachea, requiring medical or surgical intervention to remove it." | 15/06/2012 |
| Select | NICAS-494 | MDA-2012-032 | RUSCH Mackintosh laryngoscope disposable metallic kit | "RUSCH Mackintosh laryngoscope disposable metallic kit
Catalogue numbers: 670160-0000**
(** relates to blade size).
Batch numbers 041511 and 021512.
Manufactured by M.A. Arain & Brothers (PVT) Ltd.
Distributed in the UK by Teleflex (RUSCH).
There is potential for the light to fail during intubation due to a loose connection between the battery and the battery cap." | 12/06/2012 |
| Select | NICAS-493 | MDA-2012-031 | Anaesthetic machines and associated devices. All manufacturers. | "Anaesthetic machines and associated devices. All manufacturers. The Association of Anaesthetists of Great Britain and Ireland (AAGBI) report that ‘failure to
check the anaesthetic machine and/or the
breathing system features as a major
contributory factor in many anaesthetic
misadventures, including some that have
resulted in hypoxic brain damage or death’." | 06/06/2012 |
| Select | NICAS-492 | MDA-2012-030 | GEMSTAR™ bolus cord for use with GEMSTAR™ infusion pump. List number: 13027. Manufactured by Hospira | "GEMSTAR™ bolus cord for use with GEMSTAR™ infusion pump. List number: 13027. Manufactured by Hospira. Damage can occur to the bolus cord if excessive
force is used to remove it. This may result in an open or short circuit and a subsequent, unrequested bolus delivery or failure to deliver medication." | 30/05/2012 |
| Select | NICAS-491 | MDA-2012-029 | Neonatal endotracheal tube SCP clamp holder | "Neonatal endotracheal tube SCP clamp holder.
Manufactured by Capatex Medical" | 24/05/2012 |
| Select | NICAS-490 | MDA-2012-028 | Power cords and transformer boot cables of patient monitors. | "Power cords and transformer boot cables of patient monitors. Models: VSM 200 & 300 series SPOT Vital Signs SPOT LXi.
Manufactured by Welch Allyn. Risk of electric shock. Failure to unplug the monitor from the power (mains) socket prior to moving it may result in
damage to the cable and exposure of internal live parts. Welch Allyn issued a Field Safety Notice (FSN) providing advice on management of cords and transformers but has not received sufficient confirmation from users." | 23/05/2012 |
| Select | NICAS-488 | MDA-2012-026 | Dental mouth mirror manufactured by Hager & Werken GmbH & Co | "Dental mouth mirror manufactured by Hager & Werken GmbH & Co.
Model: Brillant No. 4, Lot: MD-4/31
Due to a manufacturing defect the mirror may become detached from the frame. This may present a choking hazard for patients." | 17/05/2012 |
| Select | NICAS-489 | MDA-2012-027 | Clever Chek blood glucose monitoring system - Home use blood glucose monitoring system for visually | Clever Chek blood glucose monitoring system - Home use blood glucose monitoring system for visually impaired patients - Distributed by BBI Healthcare | 17/05/2012 |
| Select | NICAS-486 | MDA-2012-024 | Endoscope accessory holder. All manufacturers. | Endoscope accessory holder. All manufacturers. Use of inappropriate accessory holders within automated endoscope reprocessors (AER) may lead to contamination of devices, equipment and processing media by retained soil and corroded material from the endoscope accessory holder. | 09/05/2012 |
| Select | NICAS-487 | MDA-2012-025 | Point of care diagnostic test for monitoring anticoagulation therapy. i-STAT PT/INR cartridges. Lots | Point of care diagnostic test for monitoring anticoagulation therapy. i-STAT PT/INR cartridges. Lots beginning with R11 or R12. Manufactured by Abbott Point of Care. There is a potential for INR results from the affected device to be falsely elevated by approximately 20%. This may lead to inadequate anticoagulation and potential thromboembolic complications | 09/05/2012 |
| Select | NICAS-485 | MDA-2012-023 | Alaris IVAC 590 series blood set - Manufactured by CareFusion | "Alaris IVAC 590 series blood set - Manufactured by CareFusion.
The manufacturer has received reports of leakage between the sleeve tubing and the drip chamber joint of the blood set.
This could lead to a delay in treatment and increase the risk of infection." | 08/05/2012 |
| Select | NICAS-483 | MDA-2012-021 | Left Ventricular Cardiac Resynchronization Therapy Leads -Manufactured By St Jude Medical | "Left Ventricular Cardiac Resynchronization Therapy Leads - Bipolar Quicksite And Quickflex Lead Models 1056t 1058t 1156t And 1158t Manufactured By St Jude Medical.
Risk of worsening heart failure symptoms due to wear and/or abrasion of lead insulation after implantation." | 24/04/2012 |
| Select | NICAS-481 | MDA-2012-019 | Air or gas pressurised spray devices for application of sprayable fibrin sealants used for intra-ope | "Air- or gas-pressurised spray devices for application of sprayable fibrin sealants used for intra-operative haemostasis.
Risk of life-threatening or fatal embolism.
The MHRA is aware of incidents of fatal air or gas embolism occurring during, or immediately after, application of fibrin sealants using air- or gas-pressurised spray devices." | 11/04/2012 |
| Select | NICAS-480 | MDA-2012-018 | AlboGraft polyester vascular graft - Manufactured by LeMaitre | "AlboGraft polyester vascular graft - Manufactured by LeMaitre.
Prohibition Notice issued
Potential for blood leakage (or other adverse incident) with these grafts. The reported leaks have occurred at implantation." | 04/04/2012 |
| Select | NICAS-479 | MDA-2012-017 | Disposable syringes and tubing used with contrast media injectors during imaging procedures - manuf | "Disposable syringes and tubing used with contrast media injectors during imaging procedures, manufactured by Covidien.
Sterility may be compromised as the packaging of these devices may not be sealed." | 04/04/2012 |
| Select | NICAS-478 | MDA-2012-016 | Metal-on-metal (MoM) total hip replacements | "MITCH TRH acetabular cups/MITCH TRH modular heads (Finsbury Orthopaedics) when implanted with uncemented Accolade femoral stems (Stryker Orthopaedics).
Increased rates of revision of metal-on-metal total hip replacements when MITCH TRH acetabular cups/MITCH TRH modular heads are used in combination with uncemented Accolade femoral stems." | 02/04/2012 |
| Select | NICAS-477 | MDA-2012-015 | Sterile indigo carmin - used as a chromoendoscopy dye during endoscopy.Manufactured by Derm Tech. | "Sterile indigo carmin - used as a chromoendoscopy dye during endoscopy.Manufactured by Derm Tech.
Supplied in the UK by Diagmed.
All product manufactured sterile." | 29/03/2012 |
| Select | NICAS-475 | MDA-2012-014 | Implantable cardioverter defibrillators (ICD). EnTrust VR/DR/AT. Models: D153ATG, D153DRG, D153VRC, | "Implantable cardioverter defibrillators (ICD). EnTrust VR/DR/AT. Models: D153ATG, D153DRG, D153VRC, D154ATG, D154DRG, and D154VRC. Manufactured by Medtronic.
Risk of loss of ICD/pacing therapy after elective replacement indicator (ERI) is reached, due to rapid battery depletion occurring approximately 2½ years after
implantation." | 16/03/2012 |
| Select | NICAS-473 | MDA-2012-012 | Patient vital signs monitor. IntelliVue models MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90, D80, | "Patient vital signs monitor.
IntelliVue models MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90, D80, MX600, MX700, MX800.
Manufactured by Philips Healthcare.
Affected software revision H up to and including H.15.36. Patient vital signs monitors may not visually or audibly alarm to alert users at the central station.
Should this occur, those monitoring the central station may not be alerted to a patient’s condition requiring intervention." | 15/03/2012 |
| Select | NICAS-474 | MDA-2012-013 | Electrosurgery instrument. LigaSure Dolphin Tip sealer/divider LS1500 and LS1520 manufactured by Cov | "Electrosurgery instrument. LigaSure Dolphin Tip sealer/divider LS1500 and LS1520 manufactured by Covidien.
Specific lot numbers.
The handle pins may disengage, possibly compromising the removal of tissue from between the jaws. I an open procedure there is an additional risk that the disengaged handle pin may fall into the patient cavity and remain unnoticed." | 15/03/2012 |
| Select | NICAS-471 | MDA-2012-010 | AlboGraft Polyester Vascular Graft: manufactured by LeMaitre. | AlboGraft Polyester Vascular Graft: manufactured by LeMaitre. All Lots. Potential for profuse bleeding (or other adverse incident) with these grafts. | 07/03/2012 |
| Select | NICAS-470 | MDA-2012-009 | Level 1® Normothermic IV fluid administration sets, specific lots of model numbers D-60 HL and DI-60 | "Level 1® Normothermic IV fluid administration sets, specific lots of model numbers D-60 HL and DI-60HL. Hotline® Blood and IV fluid warming sets, specific lots of model numbers L-70, L-70NI, L-80, L-270, and L-370. Manufactured by Smiths Medical. Smiths Medical has become aware of an increase in the number of reports of
disconnections of the Luer lock connector at the patient end of the tubing for these fluid warming sets. This can lead to a risk of fluid/ blood loss or delay in therapy.
The MHRA cannot be confident that these
recalls have been effective and that users have received and acted on the information provided in the manufacturer’s Field Safety Notices (FSNs)." | 01/03/2012 |
| Select | NICAS-469 | MDA-2012-008 | All metal-on-metal (MoM) hip replacements | All metal-on-metal (MoM) hip replacements. The MHRA is issuing updated information and advice about the management and monitoring of patients implanted with metal-on-metal (MoM) hip replacements. | 28/02/2012 |
| Select | NICAS-468 | MDA-2012-007 | Aquarius haemofiltration machine using software version 6.01. Supplied and supported by Baxter Healt | "Aquarius haemofiltration machine using software version 6.01. Supplied and supported by Baxter Healthcare Ltd.
Manufactured by Nikkiso Europe (previously
Edwards Lifesciences Ltd). The revised software upgrade version 6.02.06,
replacing software version 6.01, has been
postponed pending further validation by the manufacturer" | 23/02/2012 |
| Select | NICAS-467 | MDA-2012-006 | Histology laboratory reagents - Labelled Novocastra and Bond manufactured by Leica Biosystems | "Histology laboratory reagents:
Primary antibodies to CD2 (clone 11F11) and CD7 (clone LP15).
Labelled Novocastra and Bond both manufactured by Leica Biosystems.
Primary antibody to CD2 (clone 11F11) has been labelled as CD7 (clone LP15).
Conversely, primary antibody to CD7 (clone LP15) has been labelled as CD2 (clone 11F11)." | 20/02/2012 |
| Select | NICAS-465 | MDA-2012-004 | Reagents requiring manual handling for use in combination with cobas c501/502 analyser made by Hitac | "Reagents requiring manual handling for
use in combination with cobas c501/502
analyser made by Hitachi. Multiple tests are affected, such as syphilis (TPLA) test made by Sekisui. All supplied by Roche. The use of insufficient volumes of reagent
may lead to a false negative result leading
to patient harm such as: a missed diagnosis of syphilis, a delayed diagnosis of organ rejection, a delayed diagnosis of the end of remission for malignant lymphoma patients.
It is possible to obtain ‘valid’ but inaccurate
results when there is no reagent remaining
in the Roche cassette." | 09/02/2012 |
| Select | NICAS-464 | MDA-2012-003 | Catheter valve manufactured by Coloplast. Item number: 380851 | "Catheter valve manufactured by Coloplast. Item number: 380851 Specific lot numbers. Coloplast is recalling this product due to a
sterility issue associated with the catheter valve. These devices are normally supplied sterile. The manufacturer issued a Field Safety Notice (FSN) for this device on 10/11/2011, but has not had sufficient confirmation from users that they
have received and acted on this information. A copy of the FSN is in the appendix of this alert, and it is also available on the MHRA website." | 01/02/2012 |
| Select | NICAS-463 | MDA-2012-002 | Tracheostomy tubes: Bivona® Neonatal, Pediatric and Flextend. Manufactured by Smiths Medical. Lot nu | "Tracheostomy tubes: Bivona® Neonatal, Pediatric and Flextend.Manufactured by Smiths Medical. Lot numbers from 1631477 to 1923406 inclusive. Incorrectly connected accessories may be difficult to remove, requiring excessive force to
disconnect. This may cause the tube to
dislodge, requiring it to be changed.
The manufacturer has initiated a recall of
affected tubes.The manufacturer issued a Field Safety Notice (FSN) – dated 15 November 2011 (see appendix 2) – but has not had confirmation from
all users that they have received and acted on this information." | 19/01/2012 |
| Select | NICAS-462 | MDA-2012-001 | Rüsch Flexislip/Flexi-Slip endotracheal tube stylet with soft distal tip - 6F Manufactured by Telefl | "Rüsch Flexislip/Flexi-Slip endotracheal tube stylet with soft distal tip - 6F Manufactured by Teleflex.
Teleflex is undertaking a recall following complaints received about two problems" | 17/01/2012 |
| Select | NICAS-458 | EFA-2011-004Update | High-Voltage 11KV Switchgear – Schneider Electric - Merlin Gerin - Ringmaster RN2c RE2c and RN6c rin | "High-Voltage 11KV Switchgear – Schneider Electric - Merlin Gerin - Ringmaster RN2c RE2c and RN6c ring main units.
Potential failure of the Merlin Gerin Ring Main Unit to isolate and Earth as shown on the position indicator window - supplemented guidance" | 22/12/2011 |
| Select | NICAS-459 | MDA-2011-112 | Implantable cardioverter defibrillator ICD leads - Riata Riata ST - St Jude | "Implantable cardioverter defibrillator ICD leads - Riata Riata ST - St Jude.
Risk of inappropriate therapy due to wear and/or abrasion of lead insulation after implantation." | 22/12/2011 |
| Select | NICAS-460 | MDA-2011-113 | Octopus 3 extension set with anti-reflux valves and clamps manufactured by Vygon | "Octopus 3 extension set with anti-reflux valves and clamps manufactured by Vygon.
Product code: 0841361
Batch number: 080411AE
Possible failure to deliver therapy under gravity infusion, as these sets may be fitted with anti-syphon valves instead of anti-reflux valves." | 22/12/2011 |
| Select | NICAS-457 | MDA-2011-111 | Specific model variants of Plum A+ infusion pumps manufactured by Hospira Inc. | "Specific model variants of Plum A+ infusion pumps manufactured by Hospira Inc. List (model) numbers 11005, 11971, 11973,
12348, 12391, 12618, 20678, 20679 and
20792. This is a separate issue to Medical Device Alert MDA/2011/110 which involves some of the list numbers affected in this MDA. For this issue, there is the risk of over infusion of medication due to failure of the flow regulator." | 21/12/2011 |
| Select | NICAS-455 | EFA-2011-007 | Electrolux (Dometic) absorption pharmacy drug refrigerators - all models | "Electrolux (Dometic) absorption pharmacy drug refrigerators - all models.
Risk of ammonia gas leakage" | 19/12/2011 |
| Select | NICAS-454 | MDA-2011-110 | All Plum A+ infusion pumps manufactured by by Hospira Inc. List numbers 12391 and 20792. | "All Plum A+ infusion pumps manufactured by Hospira Inc. List numbers 12391 and 20792. Possible delay in therapy due to continuous recycling and/or rebooting if the LED display settings are adjusted from the original default settings. The manufacturer issued a Field Safety Notice
(FSN) for this device on 28/10/11, but has not had sufficient confirmation from users that they have received and acted on this information. A copy of the FSN is in the appendix of this alert, and it is also available on the MHRA website.
This alert has been issued in support of the
manufacturer’s actions." | 14/12/2011 |
| Select | NICAS-452 | EFA-2011-005 | High-Voltage (HV) 11Kv Switchgear – Siemens - Reyrolle ROK and ROKSS ring main units | "High-Voltage (HV) 11Kv Switchgear – Siemens - Reyrolle ROK and ROKSS ring main units.
Potential failure of the HV 11KV Reyrolle-ROK and ROKSS Switchgear manufactured up to and including 1982." | 13/12/2011 |
| Select | NICAS-453 | EFA-2011-006 | High-Voltage HV 11kV SIEMENS - Reyrolle Circuit Breaker – Hadrian SMV 630A | "High-Voltage HV 11kV SIEMENS - Reyrolle Circuit Breaker – Hadrian SMV 630A.
There is concern that a flashover could occur whilst isolating the circuit breaker." | 13/12/2011 |
| Select | NICAS-451 | MDA-2011-109 | Molnlycke Health Care ProcedurePaks | "Molnlycke Health Care ProcedurePaks? (various surgical procedure trays and chest drain packs)
Specific product codes and lot numbers, as detailed in the
Field Safety Notice." | 09/12/2011 |
| Select | NICAS-448 | MDA-2011-107 | Blood glucose analyser for professional use only: Glucose 201+ with Software version 106 and lower. | Blood glucose analyser for professional use only: Glucose 201+ with Software version 106 and lower. Manufactured by HemoCue AB. | 29/11/2011 |
| Select | NICAS-449 | EFA-2011-004 | High-Voltage (HV) 11KV Switchgear – Schneider Electric (Merlin Gerin) Ringmaster RN2c, RE2c and RN6c | "High-Voltage (HV) 11KV Switchgear – Schneider Electric (Merlin Gerin) Ringmaster RN2c, RE2c and RN6c ring main units.
Potential failure of the Merlin Gerin Ring Main Unit to isolate and Earth as shown on the position indicator window.
Cable can still be LIVE even when switching indicator shows the switch gear in each the positions OFF and EARTH ON." | 29/11/2011 |
| Select | NICAS-447 | MDA-2011-106 | Bathlift: Endres Riviera. Manufactured by Drive Medical Ltd. All serial numbers are affected. | Bathlift: Endres Riviera. Manufactured by Drive Medical Ltd. All serial numbers are affected. Risk of failure due to component fatigue. The user instructions have been revised to include an estimated life expectancy for the device (page 20), improved guidance regarding frequency of required maintenance and a clarification of who is responsible for this (page 13). | 09/11/2011 |
| Select | NICAS-444 | MDA-2011-103 | Wheeled walking aid: Nimbo paediatric walkers. Entire product range. Manufactured by Drive Medical L | "Wheeled walking aid: Nimbo paediatric walkers. Entire product range. Manufactured by Drive Medical Ltd.
The manufacturer has clarified that these devices are for indoor use only. The manufacturer issued a Field Safety Notice (FSN) for this device (dated 06 September 2011), but has not had sufficient confirmation from users that they have received and acted on this information.
A copy of the FSN is in the appendix of this alert, and it is also available on the MHRA website. This alert has been issued in support of the manufacturer’s actions." | 03/11/2011 |
| Select | NICAS-445 | MDA-2011-104 | Laboratory based syphilis test. Mercia Syphilis M kit manufactured by Microgen Bioproducts Limited. | "Laboratory based syphilis test. Mercia Syphilis M kit manufactured by Microgen
Bioproducts Limited. Lots 052X1, 053X1 and 05411A. Product code: M404. Higher level of non-specific cross-reactivity
leading to false positive syphilis IgM results
observed with lot numbers 052X1, 053X1 and 05411A. This may lead to misdiagnosis of early acute infection." | 03/11/2011 |
| Select | NICAS-446 | MDA-2011-105 | Rollators model number WA007 Manufactured by Drive Medical Ltd | "Rollators model number WA007 Manufactured by Drive Medical Ltd.
Risk of detachment of front castor fork during use." | 03/11/2011 |
| Select | NICAS-442 | MDA-2011-101 | Crystal Metal disposable laryngoscope blades - size Mac 4 | "Crystal® Metal disposable laryngoscope blades (size Mac 4).
Mac 3 blades have been incorrectly packaged and labelled as Mac 4 blades." | 02/11/2011 |
| Select | NICAS-443 | MDA-2011-102 | Venturi 24% 35% and 60% air entrainment jet adapters | "Venturi 24%, 35% and 60% air entrainment jet adapters. Specific lot numbers. Manufactured by Lifecare Hospital Supplies Ltd.
Potential for full or partial blockage of the Venturi oxygen outlet" | 02/11/2011 |
| Select | NICAS-441 | MDA-2011-100 | Aquarius haemofiltration device. Manufactured by NIKKISO Europe GmbH. Supplied by Baxter Healthcare. | "Aquarius haemofiltration device. Manufactured by NIKKISO Europe GmbH. Supplied by Baxter Healthcare. The manufacturer has received reports of
broken or damaged wheels on Aquarius
haemofiltration devices. The manufacturer issued a Field Safety Notice (FSN) on 20 September 2011 but has not had sufficient confirmation from users that they have
received and acted on this information" | 27/10/2011 |
| Select | NICAS-440 | EFA-2011-003 | VIE (Vacuum insulated evaporator) Main storage vessel for bulk medical oxygen supply | "VIE (Vacuum insulated evaporator) Main storage vessel for bulk medical oxygen supply.
Uncontrolled release of liquid oxygen from a vacuum insulated evaporator (VIE)." | 14/10/2011 |
| Select | NICAS-439 | EFA-2011-002 | Electric traction lifts without motor rooms | "Electric traction lifts without motor rooms. Also known as MRL lifts (machine roomless lifts).
In the event of a loss of electrical power, lift failure or breakdown passengers may be trapped in a lift." | 14/10/2011 |
| Select | NICAS-438 | MDA-2011-099 | Assura and Sensura sterile post-operative ostomy bags. Manufactured by Coloplast. Multiple product c | "Assura and Sensura sterile post-operative ostomy bags. Manufactured by Coloplast. Multiple product codes and lot numbers.
The manufacturer issued a Field Safety Notice (FSN) for this device on 21 July 2011, which they updated on 21 August 2011. Coloplast has recalled product due to a sterility issue. The MHRA cannot be confident that the recall action has been effective and that users have received and acted on this information. A copy of the FSN is in the appendix of this alertand is also available on the MHRA website.This alert has been issued in support of the manufacturer’s actions." | 06/10/2011 |
| Select | NICAS-437 | MDA-2011-098 | Legendair ventilator manufactured by Covidien.Product codes of affected devices in the UK: 4095701 a | "Legendair ventilator manufactured by
Covidien.Product codes of affected devices in the UK: 4095701 and 4095901. The manufacturer has found that, in the event
of a total mains power failure, the battery backup alarm may fail due to degradation of components necessary to power this alarm. This could result in either a total loss of the final battery alarm or a decrease in the volume or duration of the alarm." | 05/10/2011 |
| Select | NICAS-435 | MDA-2011-096 | Reusable laryngoscope handles - All models - All makes | "Reusable laryngoscope handles - All models - All makes.
The MHRA has received a coroner’s report of an inquest which found that a patient death was caused by a failure to decontaminate a laryngoscope handle appropriately between each patient use. This led to cross infection and subsequently septicaemia." | 27/09/2011 |
| Select | NICAS-434 | MDA-2011-095 | Aquarius haemofiltration machine using software version 6.01. Supplied and supported by Baxter Healt | "Aquarius haemofiltration machine using software version 6.01. Supplied and supported by Baxter Healthcare Ltd.
Manufactured by Nikkiso Europe (previously
Edwards Lifesciences Ltd). This Alert provides an update on actions advised in MDA/2009/076. The revised software version 6.02.06, replacing software version 6.01, has now been released for implementation. Baxter Healthcare Ltd will
be managing the software rollout." | 01/09/2011 |
| Select | NICAS-433 | MDA-2011-094 | All slings manufactured by Nottingham Rehab Supplies NRS and or Moving Solutions | "All slings manufactured by Nottingham Rehab Supplies (NRS) and/or Moving Solutions.
The manufacturer issued a Field Safety Notice (FSN) for these devices on 10 June 2011 but has not had sufficient confirmation from users that they have received and acted on this information." | 31/08/2011 |
| Select | NICAS-431 | MDA-2011-093 | Venflon Pro Safety peripheral IV catheter Manufactured by BD Medical | "Venflon™ Pro Safety 18GA, 1.3 x 45mm, peripheral IV catheter.
Manufactured by BD Medical.
This alert has been issued in support of the manufacturer’s actions." | 19/08/2011 |
| Select | NICAS-430 | MDA-2011-092 | Eleganza Standard and Deluxe beds manufactured by Linet prior to December 2005 | Eleganza Standard (model prefix 1GS) and Deluxe (model prefix 1GL) beds manufactured by Linet prior to December 2005 | 18/08/2011 |
| Select | NICAS-429 | MDA-2011-091 | All telescopic bed rails - model numbers HCS100 HCS105 HCS106 and HCS107 manufactured by Harvest Hea | "All telescopic bed rails (model numbers HCS100, HCS105, HCS106 and HCS107) manufactured by Harvest Healthcare Ltd.
The manufacturer issued a Field Safety Notice (FSN) for this device on 19 January 2011, but has not had sufficient confirmation from users that they have received and acted on this information." | 18/08/2011 |
| Select | NICAS-428 | MDA-2011-090 | Umbilical Cord Clamp | "Umbilical Cord Clamp. Manufactured by Farla Medical Ltd. Product code: 7005
Batch number: 81010 NHS Supply Chain code: FFK112 (England only). Device supplied in England only. The manufacturer issued a Field Safety Notice (FSN) for this device on 28 June 2011, but has not had sufficient confirmation from users that
they have received and acted on this
information." | 16/08/2011 |
| Select | NICAS-427 | MDA-2011-089 | Sterile 2ml Luer lock hypodermic syringe.Manufactured by Codan Limited. Product code 622637 NHSSC co | "Sterile 2ml Luer lock hypodermic syringe.
Manufactured by Codan Limited. Product code 622637 NHSSC code FWC053 (England only). Batch number F85319-1. The manufacturer issued a Field Safety Notice (FSN) for this device on 09 June 2011, but has had insufficient confirmation from users that they have received and acted on this information. A copy of the FSN is in the appendix of this alert, and it is also available on the MHRA website. This alert has been issued in support of the
manufacturer’s actions." | 04/08/2011 |
| Select | NICAS-426 | MDA-2011-088 | ROLKO strap and handle assembly, model TGN-R100GR, manufactured by Rolko GmbH. | "ROLKO strap and handle assembly, model
TGN-R100GR, manufactured by Rolko GmbH.
Fitted to a monkey pole and supplied in the UK by ArjoHuntleigh. The affected products were manufactured from January 2007 to January 2009 inclusive. ArjoHuntleigh issued a Field Safety Notice (FSN) for this device on 07 July 2011, but has not had
sufficient confirmation from users that they have received and acted on this information. A copy of the FSN is in the appendix of this alert, and it is also available on the MHRA website." | 01/08/2011 |
| Select | NICAS-422 | MDA-2011-084 | Blood gas analysers. Manufactured by Radiometer. Models ABL505/555, EML105, ABL600, ABL700 Series an | "Blood gas analysers. Manufactured by Radiometer. Models ABL505/555, EML105, ABL600, ABL700 Series and ABL800. Calcium membrane units, ordering numbers 942-046 and 942-060.
Potential for biased blood calcium results which may affect diagnosis and treatment of hypocalcaemia.
Calcium membrane units may need to be
replaced more frequently. The manufacturer has reported that wrinkles
may form in calcium membrane units. Retention of fluids between the wrinkles can cause a positive bias of approximately 14% in whole blood at low calcium levels (around 0.80mmol/L)." | 27/07/2011 |
| Select | NICAS-423 | MDA-2011-085 | Transactive and Transportable overhead hoists manufactured by Waverley Glen. Supplied in the UK by F | "Transactive and Transportable overhead hoists manufactured by Waverley Glen.
Supplied in the UK by Freeway Healthcare Ltd (now Prism Medical UK) from June 2000 to August 2003 inclusive. The manufacturer issued a Field Safety Notice (FSN) for this device on 10 June 2011, but has not had sufficient confirmation from users that
they have received and acted on this
information. A copy of the FSN is in the appendix of this alert, and it is also available on the MHRA website.
This alert has been issued in support of the
manufacturer’s actions." | 27/07/2011 |
| Select | NICAS-424 | MDA-2011-086 | Oxford Easytrack systems for use with overhead hoists. Manufactured by BHM Medical. Supplied in the | "Oxford Easytrack systems for use with
overhead hoists. Manufactured by BHM Medical. Supplied in the UK by Joerns Healthcare Ltd. The manufacturer issued a Field Safety Notice (FSN) for this device on 8 April 2011, but has not had sufficient confirmation from users that
they have received and acted on this
information.
A copy of the FSN is in the appendix of this
alert, and it is also available on the MHRA
website.This alert has been issued in support of the manufacturer’s actions." | 27/07/2011 |
| Select | NICAS-425 | MDA-2011-087 | Rollator models 2320, 2340, 2462 and 2463 manufactured by Roma Medical Aids Ltd. Serial numbers begi | "Rollator models 2320, 2340, 2462 and 2463 manufactured by Roma Medical Aids Ltd. Serial numbers beginning TVD1002 or TVD1003. The manufacturer issued a Field Safety Notice (FSN) for this device on 24 May 2011, but has not had sufficient confirmation from users that
they have received and acted on this
information.
A copy of the FSN is in the appendix of this
alert, and it is also available on the MHRA
website.
This alert has been issued in support of the
manufacturer’s actions." | 27/07/2011 |
| Select | NICAS-421 | MDA-2011-083 | Durewall handling belt supplied in the UK by Prism Medical, order codes DUR03, DURMED and DURLGE. | "Durewall handling belt supplied in the
UK by Prism Medical, order codes DUR03, DURMED and DURLGE. The product is labelled as manufactured by Etac, Etac Immedia or Immedia with article numbers (IM) 8010509, 8010513, 8013009, 8013013, 8015013 and 8017015. These belts were supplied before January 2011." | 22/07/2011 |
| Select | NICAS-420 | MDA-2011-082 | HandyVac™ low vacuum surgical wound drainage systems and accessories. | "HandyVac™ low vacuum surgical wound drainage systems and accessories.
Manufactured by Unomedical a/s – a ConvaTec company. Specific product ID codes (reference numbers) and lot
numbers are affected – see appendix." | 21/07/2011 |
| Select | NICAS-419 | MDA-2011-081 | Ophthalmic surgical instrument. Cryomatic probes manufactured by Keeler Ltd. | "Ophthalmic surgical instrument. Cryomatic probes manufactured by Keeler Ltd.
All probes are affected. The manufacturer has not validated the 134-137°C for 3 minutes steam sterilisation method
for Cryomatic probes. The instructions for use were updated in September 2010 to remove this method of sterilisation.
The current recommended method is steam
sterilisation by gravity at 121-124°C for 30
minutes. The packaging and storage
instructions for this method are insufficiently described in the instructions for use." | 18/07/2011 |
| Select | NICAS-416 | MDA-2011-079 | Implantable Pulse Generators - Mnaufacturered by St Jude Medical | "Implantable Pulse Generators (IPGs) – Neurostimulators.
Eon Mini™ (Model 65-3788) and Brio™ (Model 65-6788).
Manufactured by St Jude Medical.
Faulty battery components have resulted in some IPGs losing the ability to communicate with the programmer or recharge. In the cases reported, the duration between recharges became progressively shorter until the IPG failed to charge or there was a sudden loss of power, which resulted in the need for device replacement. The time from manufacture of affected devices to explant has so far ranged from 8 months to 2 years." | 14/07/2011 |
| Select | NICAS-417 | MDA-2011-080 | Invasive blood pressure monitoring (IBPM) systems: LogiCal®, NovaTrans®, and TranStar® Manufactured | "Invasive blood pressure monitoring (IBPM) systems: LogiCal®, NovaTrans®, and TranStar® Manufactured by Smiths Medical.
Specific models and lot numbers are affected. Specific lot numbers are being recalled due to reports of the tubing separating from the connectors, resulting in leaks or disconnections. This could lead to blood loss, contamination of the fluid path, or air ingress into the system." | 14/07/2011 |
| Select | NICAS-418 | EFA-2011-001 | Domestic type BEKO and LEC fridge freezers | "Domestic type BEKO / LEC fridge freezers
(various colours)
Recall of BEKO / LEC domestic type fridge freezers manufactured between January 2000 and October 2006, due to a faulty defrost timer switch." | 14/07/2011 |
| Select | NICAS-413 | MDA-2011-076 | Level 1® Normothermic IV fluid administration sets for use with the Level 1® Fast Flow fluid warmer | "Level 1® Normothermic IV fluid administration sets for use with the
Level 1® Fast Flow fluid warmer units.
Manufactured by Smiths Medical.
All lots of model numbers F-50, DI-65HL, DI-75, DI-150 and DI-350.
Risk of delay in treatment due to:
1. Ongoing issue of tube kinking,
previously highlighted in MDA/2011/031
(now superseded).
2. New issue of leaking at the F-50 gas
vent filter assembly.
The manufacturer is undertaking a second
recall of sets that have the F-50 gas vent filter. However, replacement sets are not equippedwith F-50 gas vent filter assembly and so there is an increased risk of air embolism." | 07/07/2011 |
| Select | NICAS-414 | MDA-2011-077 | Level 1® Normothermic IV fluid administration sets for use with the Level 1® Fast Flow fluid warmer | "Level 1® Normothermic IV fluid administration sets for use with the
Level 1® Fast Flow fluid warmer units.
Manufactured by Smiths Medical.
Specific lots of model numbers D-60HL and DI-60HL. This IV fluid administration set has a heat exchanger assembly that may be too long to fit into Fast Flow fluid warmers, making the set unusable.
This could delay treatment while another
administration set or an alternative method of fluid warming is obtained." | 07/07/2011 |
| Select | NICAS-415 | MDA-2011-078 | 28% air entrainment (white Venturi) jet adapter for use with oxygen facemasks. Manufactured by Medit | "28% air entrainment (white Venturi) jet adapter for use with oxygen facemasks.
Manufactured by Meditech Systems Ltd.
Supplied by various distributors. Specific lot numbers are affected.
Risk of inadequate oxygen supply. All devices manufactured from July 2009 to April 2010 inclusive are being recalled due to an intermittent fault in the moulding process which may result in occlusion of the jet." | 07/07/2011 |
| Select | NICAS-412 | MDA-2011-075 | Headrests attachment to operating tables with connection fixture: 1002.65A0 or 1002.65S0 | Headrests attachment to operating tables with connection fixture: 1002.65A0 or 1002.65S0. Manufactured by Maquet Ltd. The manufacturer issued a Field Safety Notice (FSN) for this device on 12 May 2011, but has not had sufficient confirmation from users that they have received and acted on this information. | 06/07/2011 |
| Select | NICAS-411 | MDA-2011-074 | Cortoss Delivery Gun - used to deliver Cortoss Bone Augmentation Material | "Cortoss™ Delivery Gun - used to deliver Cortoss™ Bone Augmentation Material.
Manufactured by Orthovita Inc.
Distributed in the UK by Orthovita UK Ltd.
The manufacturer issued a Field Safety Notice (FSN) for this device on 15 April 2011, but has not had sufficient confirmation from users that they have received and acted on this information." | 05/07/2011 |
| Select | NICAS-410 | MDA-2011-073 | Implantable cardioverter defibrillator (ICD). | "Implantable cardioverter defibrillator (ICD).
Paradym, model numbers: VR 8250, DR 8550, CRT-D 8750 and 8770, VR 9250, DR 9550, CRT-D 9750 and 9770. Manufactured by Sorin CRM. Risk of bradycardia / syncope due to pacing inhibition. Potential for pacing inhibition associated with
ventricular oversensing if the follow-up
monitoring feature, PhD, is programmed ON
and the device is connected to high polarisation defibrillation leads. The manufacturer issued a Field Safety Notice
(FSN) on 27 April 2011." | 29/06/2011 |
| Select | NICAS-409 | MDA-2011-072 | Caretex Urinals (PHURI046) manufactured by PH Medisavers. | "Caretex Urinals (PHURI046) manufactured by PH Medisavers. Lot no. 1011294 NHS Supply Chain no. FWV042. The manufacturer issued a Field Safety Notice
(FSN) on 14 June 2011 recalling this batch of the device but has not had sufficient
confirmation from users that they have received and acted on this information." | 22/06/2011 |
| Select | NICAS-408 | MDA-2011-071 | Ophthalmic surgical instrument. Cryomatic probes manufactured by Keeler Ltd. All probes are affecte | "Ophthalmic surgical instrument. Cryomatic probes manufactured by Keeler Ltd.
All probes are affected. The instructions for use contain inadequately validated re-processing methods. As a result there is a risk of cross infection." | 21/06/2011 |
| Select | NICAS-406 | MDA-2011-069 | Pelispec vaginal specula including those with smoke extractor, those in light source packs and IUD p | "Pelispec vaginal specula including those with smoke extractor, those in light source packs and IUD procedure packs. Manufactured by Pelican Feminine Healthcare. All product codes.
Lot numbers: week 18/2006 to week 17/2011 inclusive.
The peel pouch of approximately 1% of these products may be damaged and the sterility compromised.
The manufacturer has recalled all products in these specified lot numbers." | 20/06/2011 |
| Select | NICAS-407 | MDA-2011-070 | All pyramid clamp adaptors Part No 409054 manufactured by Blatchford Products Ltd between October 20 | "ll pyramid clamp adaptors Part No 409054 manufactured by Blatchford Products Ltd between October 2007 and February 2011.
The adaptor is also contained in some transtibial pyramid kits.
A small number of incidents have occurred where this adaptor has cracked unexpectedly, resulting in a fall and injury to the user. The manufacturer issued a Field Safety Notice (FSN) on 18 April 2011 calling for the adaptor to be replaced as soon as possible. However, the manufacturer has not received sufficient information to demonstrate that the FSN has been acted upon." | 20/06/2011 |
| Select | NICAS-404 | MDA-2011-067 | Subcutaneous implantable cardioverter defibrillator (S-ICD): SQ-RX® pulse generator, model 1010. | "Subcutaneous implantable cardioverter defibrillator (S-ICD): SQ-RX® pulse generator, model 1010. Manufactured by Cameron Health. Risk of S-ICD being unable to deliver shock for therapy after elective replacement indicator (ERI) audible warning. The ERI may occur earlier than expected and the end of life (EOL) indicator may occur before the nominal 3 months.
The manufacturer has identified 2 populations of devices in the UK that are at higher risk of premature battery depletion.
Population 1: 33% risk of premature battery failure over 5 years – 3 devices in the UK. Population 2: 3.3% risk of premature battery failure over 5 years – 81 devices in the UK." | 14/06/2011 |
| Select | NICAS-401 | MDA-2011-064 | Automatic external defibrillators (AEDs): DDU-100 series with 2.004 software or earlier. Manufacture | "Automatic external defibrillators (AEDs): DDU-100 series with 2.004 software or earlier. Manufactured by Defibtech. Marketed under the brand names Lifeline AED, ReviveR AED and Lifeforce.
The manufacturer issued a Field Safety Notice (FSN) for this device on 11 March 2011, but has not had sufficient confirmation from users that they have received and acted on this information." | 07/06/2011 |
| Select | NICAS-402 | MDA-2011-065 | Alcohol skin preparation pads, swabs and swabsticks manufactured by Triad Group Inc since 2007 | "Alcohol skin preparation pads, swabs and swabsticks manufactured by Triad Group Inc since 2007.
Supplied in various device packs manufactured by:
- Smith & Nephew Wound Management
- Neuro Resource Group Inc.
The manufacturers issued Field Safety Notices (FSN) for these devices in April 2011, but have not had sufficient confirmation from users that they have received and acted on this information." | 07/06/2011 |
| Select | NICAS-400 | MDA-2011-063 | Neonatal resuscitation systems - Manufactured by Intersurgical Ltd | "Neonatal resuscitation systems - Manufactured by Intersurgical Ltd.
Product codes 6181, 6308, 6315, 6354, 6354001 and 6356 are affected.
The manufacturer issued a Field Safety Notice (FSN) for this device on 19 May 2011." | 06/06/2011 |
| Select | NICAS-398 | MDA-2011-061 | Power supply for TruSat Pulse Oximeter | "Power supply for TruSat Pulse Oximeter.
Manufactured by GE Healthcare.
Part numbers: TR9CE1250LRDP-Y-MED
TR9CE1250LR2P-Y-MED
The plastic cases of the external power supply for GE TruSat pulse oximeters may break, exposing live parts, or may overheat and deform. This presents a risk of electric shock or burns to users." | 06/06/2011 |
| Select | NICAS-399 | MDA-2011-062 | Various devices manufactured by Boston Scientific stolen prior to sterilisation | "Various devices manufactured by Boston Scientific stolen prior to sterilisation.
The manufacturer issued a Field Safety Notice (FSN) on 10 May 2011 for these devices that were stolen before they were sterilized, although labelled as ‘sterile’." | 06/06/2011 |
| Select | NICAS-397 | MDA-2011-060 | Dual Chamber Pacemakers | The manufacturer issued a Field Safety Notice (FSN) – Medtronic Reference: FA507 – for these devices on 4 April 2011, but has not had sufficient confirmation from users that they have received and acted on this information. | 02/06/2011 |
| Select | NICAS-396 | MDA-2011-059 | Click-Style gas regulator for pin-index oxygen cylinders. Manufactured by Amvex Corporation. All mod | "Click-Style gas regulator for pin-index oxygen cylinders. Manufactured by Amvex
Corporation. All models are affected.
The manufacturer issued a Field Safety Notice (FSN) for this device on 8 March 2011, but has not had sufficient confirmation from users that they have received and acted on this information.
A copy of the FSN is in the appendix of this
alert, and it is also available on the MHRA
website. This alert has been issued in support of the manufacturer’s actions." | 01/06/2011 |
| Select | NICAS-394 | MDA-2011-057 | BLAKE - Silicone Drain, Silicone Drain Kit, Cardio Connector J-VAC - Reservoir, Drain Adapter | "BLAKE - Silicone Drain, Silicone Drain Kit, Cardio Connector J-VAC - Reservoir, Drain Adapter - Manufactured by Ethicon
Multiple product codes and lot numbers.
This Alert has been issued in support of the manufacturer’s actions." | 26/05/2011 |
| Select | NICAS-395 | MDA-2011-058 | Enteral feeding pump: Applix Smart and Applix Vision Nutrition pumps | "Enteral feeding pump: Applix Smart and Applix Vision Nutrition pumps. Serial numbers from 1998xxxx to 2010xxx, where x is a digit. Manufactured by Fresenius Kabi.
Risk of under-delivery of enteral feed.
Following an increase in the number of reports of undetected occlusions, Fresenius Kabi has initiated a maintenance check of specific pumps." | 26/05/2011 |
| Select | NICAS-393 | MDA-2011-056 | Pacemaker. Reply and Esprit models that have been interrogated with programmer containing software v | "Pacemaker. Reply and Esprit models that have been interrogated with programmer containing software version 2.24.
Manufactured by Sorin CRM." | 25/05/2011 |
| Select | NICAS-392 | MDA-2011-055 | eXpert DC Intraoral X-Ray systems - Manufactured by Gendex Dental Systems and supplied by KaVo Denta | "eXpert DC Intraoral X-Ray systems, batches shipped between April 2010 and August 2010.
Manufactured by Gendex Dental Systems and supplied by KaVo Dental Ltd." | 23/05/2011 |
| Select | NICAS-390 | MDA-2011-053 | Wound dressing. PremierPore vapour permeable island dressing.Manufactured by Shermond.Specific lot n | "Wound dressing. PremierPore vapour permeable island dressing.
Manufactured by Shermond. Specific lot numbers.
The manufacturer issued a Field Safety Notice (FSN) for this device on 16 March 2011, but has not had sufficient confirmation from users that they have received and acted on this information." | 20/05/2011 |
| Select | NICAS-391 | MDA-2011-054 | Level 1® Normothermic IV fluid administration sets for use with the Level 1 fast flow fluid warmer u | "Level 1® Normothermic IV fluid administration sets for use with the Level 1 fast flow fluid warmer units. Manufactured by Smiths Medical.All lots of model numbers DI-60HL, DI-50 and DI-100.
The manufacturer issued a Field Safety Notice (FSN) for this device (dated 29 April 2011), but has not had sufficient confirmation from users that they have received and acted on this information." | 20/05/2011 |
| Select | NICAS-389 | MDA-2011-052 | Topical skin adhesive Dermabond Manufactured by Ethicon Products J&J Medical Ltd | "Topical skin adhesive.
Dermabond (product code AHV12 Lots: CJP841 and CKE811) and Dermabond Mini (product code AHVM12 Lot: CKE512).
Manufactured by Ethicon Products, J&J Medical Ltd.
The manufacturer issued a Field Safety Notice (FSN) for this device on 4 February 2011, but has not had sufficient confirmation from users that they have received and acted on this information." | 19/05/2011 |
| Select | NICAS-387 | MDA-2011-050 | Smart 150 mobile hoists manufactured by Molift Group AS distributed in the UK by Meditec Medical Ltd | "Smart 150 mobile hoists manufactured by Molift Group AS, distributed in the UK by Meditec Medical Ltd - Model number: 0920008 Specific serial numbers affected.
The manufacturer issued a Field Safety Notice (FSN) for this device on 30 March 2011, but has not had sufficient confirmation from users that they have received and acted on this information." | 18/05/2011 |
| Select | NICAS-385 | MDA-2011-048 | Heavy Duty Rollator – titanium coloured | Heavy Duty Rollator – titanium coloured Model Number – L97986. Manufactured by Nottingham Rehab Supplies (NRS). | 17/05/2011 |
| Select | NICAS-386 | MDA-2011-049 | Powder free examination gloves Latex - LMPF100 and Vinyl - FT100 and MPF25 - Manufactured by BM Pol | "Powder free examination gloves Latex - LMPF100 and Vinyl - FT100 and MPF25 - Manufactured by BM Polyco Ltd.
Gloves from the affected lots may have pinholes, which could increase the risk of cross infection and leakage.
This alert has been issued in support of the manufacturer’s actions to ensure that all relevant healthcare staff are aware of the problem." | 17/05/2011 |
| Select | NICAS-383 | MDA-2011-046 | Disposable laryngoscope blade manufactured by Penlon Ltd | Disposable laryngoscope blade - Crystal Metal Miller disposable blades (sizes 0 and 00) - Manufactured by Penlon Ltd | 16/05/2011 |
| Select | NICAS-384 | MDA-2011-047 | Powerheart AED G3 and CardioVive automatic external defibrillators | Powerheart AED G3 and CardioVive automatic external defibrillators (AED). Manufactured by Cardiac Science Corporation. Specific models and serial numbers affected. | 16/05/2011 |
| Select | NICAS-382 | MDA-2011-045 | Molnlycke Health Care Procedure Pak®s (for lipolysis and sperm retrieval) containing BD Microlance 3 | "Molnlycke Health Care Procedure Pak®s (for lipolysis and sperm retrieval) containing BD Microlance 30G x 1/2” hypodermic needle. Product codes 97016297-01 & 97031992-00. Specific lot numbers. The manufacturer issued a Field Safety Notice (FSN) for these devices in March 2011, but has not had sufficient confirmation from users that they have received and acted on this information.
A copy of the FSN is in the appendix of this
alert, and it is also available on the MHRA
website. This alert has been issued in support of the manufacturer’s actions." | 13/05/2011 |
| Select | NICAS-381 | MDA-2011-044 | StatStrip Glucose manufactured by Nova Biomedical | "Blood glucose meters for professional use only: StatStrip Glucose manufactured by Nova Biomedical.
The meter may generate consecutive error codes for multiple samples from the same patient, which may mask abnormal glucose levels." | 12/05/2011 |
| Select | NICAS-379 | MDA-2011-042 | Romachair Anti Microbial Commode, models 4730/4740, manufactured by Roma Medical Aids Ltd. | "Romachair Anti Microbial Commode, models 4730/4740, manufactured by Roma Medical
Aids Ltd. The manufacturer issued a Field Safety Notice (FSN) for this device on 21 February 2011, but has not had sufficient confirmation from users that they have received and acted on this information.
A copy of the FSN is in the appendix of this
alert, and it is also available on the MHRA
website.
This alert has been issued in support of the
manufacturer’s actions." | 11/05/2011 |
| Select | NICAS-380 | MDA-2011-043 | Surgical gloves, Biogel Eclipse Reveall 608, Manufactured by Molnlycke Health Care | "Surgical gloves, Biogel Eclipse Reveall 608, Manufactured by Molnlycke Health Care.
The manufacturer issued a Field Safety Notice (FSN) for this product in April 2011, but has not had sufficient confirmation from users that they have received and acted on this information." | 11/05/2011 |
| Select | NICAS-378 | MDA-2011-041 | T34 syringe pump sets manufactured before 01 January 2011. Product codes 100-172S, 100-170S, 100-172 | T34 syringe pump sets manufactured before 01 January 2011. Product codes 100-172S, 100-170S, 100-172SLL, 100-172SB, 100-172SC. Manufactured by CME (McKinley Medical UK). Recall of extension sets manufactured before 01 January 2011 due to the potential for leakage at the female Luer (syringe) connector. | 27/04/2011 |
| Select | NICAS-377 | MDA-2011-040 | Eclipse treatment planning system. Manufactured by Varian Medical Systems Inc. | "Eclipse treatment planning system.
Manufactured by Varian Medical Systems Inc. Potential for incorrect radiotherapy dose.
When editing or changing the multi leaf
collimator (MLC) using Eclipse, the dose plan may not recalculate automatically, as expected.
This problem occurs intermittently.
Therefore, users should be extra vigilant, as they may not receive a warning that a dose recalculation is necessary.
Varian is investigating this problem." | 21/04/2011 |
| Select | NICAS-376 | MDA-2011-039 | Sunrise Medical - Quickie Neon Swing- Away manual wheelchairs, with a seat depth of 44cm or less, ma | "Sunrise Medical - Quickie Neon Swing-
Away manual wheelchairs, with a seat
depth of 44cm or less, manufactured
before June 2010. The upper frame tubes that support the backrest can fail during use, leading to a fall for the user or the carer.
Sunrise issued a Field Safety Notice
(SM/FSN/NSA) (click here) in February 2011,
but has been unable to trace all end users." | 20/04/2011 |
| Select | NICAS-375 | MDA-2011-038 | Oxygen masks and face tent masks - Manufactured by Unomedical | "Oxygen masks and face tent masks - Manufactured by Unomedical.
Degradation of the plastic within six to eight months of manufacture can result in a sticky substance appearing inside and/or outside the mask." | 19/04/2011 |
| Select | NICAS-374 | MDA-2011-037 | Sterile urine drainage bags – various volumes, tube lengths and presentations. Manufactured by Unome | "Sterile urine drainage bags – various volumes, tube lengths and presentations. Manufactured by Unomedical a/s (a ConvaTec Company). Specific product codes and lot numbers.
The connector, which attaches the urine drainage bag to the patient’s catheter, may be partially or completely blocked, restricting or preventing drainage of urine into the bag. This may result in retention of urine in the bladder. The manufacturer recalled affected products in November 2010. The MHRA is issuing this Medical Device Alert to reach users who may remain unaware of this recall." | 14/04/2011 |
| Select | NICAS-372 | MDA-2011-035 | HLA (human leukocyte antigen) tissue typing kits.RELI SSO HLA-B, DRB, DQB1, DRB1, A, Cw and related | "HLA (human leukocyte antigen) tissue typing kits. RELI SSO HLA-B, DRB, DQB1, DRB1, A, Cw and related Mastermixes manufactured by Invitrogen. All lots manufactured since 2004.
This is an update to an existing Medical Device Alert MDA/2011/014. More products are affected.
Product has been released with expired oligonucleotide probes and primers in the absence of sufficient stability data to support this practice.
This may result in weak or negative results which may result in a no-type or mistype. Potential additional mismatches may have been hidden and may not have been identified. Furthermore, potentially compatible HLA matches may have been missed on the basis of this misinterpretation." | 13/04/2011 |
| Select | NICAS-373 | MDA-2011-036 | Alaris® infusion set GP 150ml burette set. Alaris® GP infusion set, low sorbing, 0.2mm filter.Manufa | "Alaris® infusion set GP 150ml burette set.
Product reference 60103E. Alaris® G P infusion set, low sorbing, 0.2mm filter.
Product reference 60033E. Manufactured by Carefusion.Specific lot numbers are affected.
Potential for leakages and/or set disconnections in devices from specific lots due to a manufacturing problem.
The MHRA is issuing this alert as there has
been a poor response from users to the
Carefusion Field Safety Notices, which have
been sent to affected customers." | 13/04/2011 |
| Select | NICAS-371 | MDA-2011-034 | Philips - CT Scanner | "CT Scanner - Brilliance 6 (Air), 10 (Air), 16 (Air), 16P, 40, 64, Big Bore, iCT and iCT SP Manufactured by Philips Healthcare.
Potential for CT scanner table to collapse with a patient on the table." | 12/04/2011 |
| Select | NICAS-370 | MDA-2011-033 | Optilube lubricating jelly supplied as 150 x 5g sachets per box | "Optilube lubricating jelly supplied as 150 x 5g sachets per box - Lot 25092010. Manufactured by Optimum Medical Solutions.
Part of the specified lot number was found to be non-sterile and contaminated with the yeast Candida guilliermondi, which can cause infection in patients that may be immunocompromised and those with malignancy." | 07/04/2011 |
| Select | NICAS-369 | MDA-2011-032 | Airtraq single-use optical laryngoscope manufactured by DragonHeart Medical Co Ltd. Supplied by Fann | "Airtraq single-use optical laryngoscope manufactured by DragonHeart Medical Co Ltd. Supplied by Fannin UK. Specific models and lot numbers affected. Due to battery failure the laryngoscope’s optical
display may fail to work. The manufacturer is conducting a recall of specific lots.
The MHRA is issuing this alert as there has
been a poor response from users to recall
notifications." | 05/04/2011 |
| Select | NICAS-367 | MDA-2011-030 | Action 3 Junior manual wheelchairs manufactured by Invacare. Serial numbers from 050714224781 to 051 | "Action 3 Junior manual wheelchairs manufactured by Invacare. Serial numbers from 050714224781 to 051021027909 (inclusive) fitted with the attendant push bar.
Failure of the push bar clamping brackets, resulting in a loss of control and the potential for serious injury to the user or attendant." | 29/03/2011 |
| Select | NICAS-368 | MDA-2011-031 | Smith Medical - Level 1 Normothermic IV fluid administration sets | "Smith Medical - Level 1 Normothermic IV fluid administration sets for use with the Level 1 fast flow fluid warmer units. All lots of model numbers DI-65HL, DI-75 and DI-150.
Design fault in the clamp position, resulting in kinking of the tube and reduced flow." | 29/03/2011 |
| Select | NICAS-366 | MDA-2011-029 | Haemodialysis machine - Manufactured by Gambro Lundia AB | "Haemodialysis machine - Manufactured by Gambro Lundia AB.
• | 24/03/2011 |
| Select | NICAS-364 | MDA-2011-027 | Xtreme, Graduate, Junior and Stand-up hoists and standing aids branded and distributed by Harvest He | "Xtreme, Graduate, Junior and Stand-up hoists and standing aids branded and distributed by Harvest Healthcare between May 2004 and March 2006. Risk of electric shock when the hoist is connected to the mains supply with a single insulated power cable for battery charging.
Harvest Healthcare issued a Field Safety Notice (dated 17 January 2011) but has been unable to trace all users." | 18/03/2011 |
| Select | NICAS-365 | MDA-2011-028 | Microlance 30G x ½” sterile hypodermic needle manufactured by BD Medical. Product code 304000.Specif | "Microlance 30G x ½” sterile hypodermic
needle manufactured by BD Medical.
Product code 304000.Specific lot numbers.
These needles, used for a variety of clinical
procedures, may be blocked or partially blocked.
The manufacturer is recalling the affected devices and has issued a Field Safety Notice (see appendix) to its customers. The MHRA has issued this MDA to ensure that all users are aware of the problem." | 18/03/2011 |
| Select | NICAS-362 | MDA-2011-025 | Endotracheal (ET) tubes, adult and paediatric sizes | "Endotracheal (ET) tubes, adult and paediatric sizes. Manufactured by Unomedical (a ConvaTec company).
The manufacturer has issued new instructions for use advising against the cutting of their endotracheal tubes. If the tube is shortened it can be difficult to reattach the ET tube connector." | 14/03/2011 |
| Select | NICAS-361 | MDA-2011-024 | The Great Ormond Street GOS tracheostomy cannula set manufactured by Teleflex Medical | "The Great Ormond Street GOS tracheostomy cannula set manufactured by Teleflex Medical (formerly known as Rusch). All lot numbers of the following part
numbers are affected: 121001 121002 121003 858812 858813. Due to a manufacturing error, the tube is too
straight. Teleflex has initiated a product recall. Teleflex is not aware of any incidents of injury related to this issue. However, if the tube is too straight, there is a risk of damage to the tracheal wall during insertion or over time following insertion." | 07/03/2011 |
| Select | NICAS-360 | MDA-2011-023 | Alcohol skin preparation pads, swabs, and swabsticks manufactured by Triad Group Inc for H&W cv sinc | "Alcohol skin preparation pads, swabs, and swabsticks manufactured by Triad Group Inc for H&W cv since 2007. Also supplied in various manufacturers’ drug administration kits, needle exchange packs, and other device packs. Potential bacterial contamination of alcohol swabs which may lead to skin infection.
Immunocompromised individuals are at greater risk of serious infection.
This is confined to the alcohol swabs and
does not affect the medicines or other
components of the drug administration kits
or device packs.
This MDA updates MDA/2011/013 (issued on 11 February 2011) with details of additional manufacturers’ device packs and kits that contain the affected swabs." | 03/03/2011 |
| Select | NICAS-359 | MDA-2011-022 | Sutures manufactured by ETHICON | "The unit pack in the affected products may not have a complete seal and so the contents may not be sterile.
There is a risk of infection if non-sterile sutures are used." | 02/03/2011 |
| Select | NICAS-357 | MDA-2011-020 | Oxford Voyager 420, 550 & 800 fixed ceiling hoist system fitted with X-Y gate system (part ref: VOY- | "Oxford Voyager 420, 550 & 800 fixed ceiling hoist system fitted with X-Y gate
system (part ref: VOY-700.07500). Manufactured by BHM Medical, supplied by Sunrise Medical or Joerns Healthcare.
Due to insufficient information in the installation, inspection and maintenance instructions this hoist may detach from the track during use. This would result in serious injury to the occupant or
others.
Joerns Healthcare issued a Field Safety Notice (dated 17 September 2010) incorporating revised instructions but has been unable totrace all users." | 23/02/2011 |
| Select | NICAS-358 | MDA-2011-021 | Gemstar pump sets used for epidural infusions or total parenteral feeding (TPN). Manufactured by Hos | "Gemstar pump sets used for epidural infusions or total parenteral feeding (TPN).
Manufactured by Hospira. Hospira has initiated a product recall due to the
potential for under-delivery when these sets are used at flow rate settings of less than 10ml/hour." | 23/02/2011 |
| Select | NICAS-356 | MDA-2011-019 | Careline Easi-MT urine collection bag manufactured by Unomedical a/s. | Careline Easi-MT urine collection bag manufactured by Unomedical a/s. Product code 47-60-LBH. Affected lot numbers: 373957 376580 378508 380213 383766 384390 387803. NHS Supply Chain code: GDW031 (England only). A faulty valve has been used in the manufacture of these batches resulting in leakage of contents. | 21/02/2011 |
| Select | NICAS-355 | MDA-2011-018 | Action 3 NG manual wheelchairs manufactured by Invacare, fitted with the angle adjustable backrest. | Action 3 NG manual wheelchairs manufactured by Invacare, fitted with the angle adjustable backrest. Due to poor welding during manufacture, the backrest can fail during use, leading to a fall for the user or the carer. Invacare issued a Field Safety Notice (FSN034) in October 2010 but has been unable to trace all users, especially where the backrest has been supplied as a spare part. | 17/02/2011 |
| Select | NICAS-354 | MDA-2011-017 | Breast implants.All types, makes and models. | "Breast implants.All types, makes and models. There is uncertain evidence that women with breast implants may have a very small but increased risk of anaplastic large cell lymphoma (ALCL) of the breast.
The MHRA has not received any adverse
incident reports identifying ALCL in association with breast implants in the UK. Discussions with the relevant UK professional bodies have not identified any cases." | 16/02/2011 |
| Select | NICAS-353 | MDA-2011-016 | PleuraSealTM Lung Sealant System manufactured by Covidien. Product code PLS-005. All lots. | "PleuraSealTM Lung Sealant System manufactured by Covidien. Product code PLS-005. All lots. Recall of all lots of these devices due to persistent air leaks following pulmonary resection surgery.
The MHRA is issuing this alert because the
manufacturer has been unable to confirm that all users of these devices have received their Field Safety Notice." | 15/02/2011 |
| Select | NICAS-351 | MDA-2011-014 | HLA (human leukocyte antigen) tissue typing kits | "HLA (human leukocyte antigen) tissue typing kits. RELI SSO HLA-B, DRB, DQB1 and DRB1 manufactured by Invitrogen.
All lots manufactured since 2004." | 14/02/2011 |
| Select | NICAS-352 | MDA-2011-015 | Oxygen Masks - Lifecare Hospital Supplies Ltd | "Oxygen masks - L2000 & L2001/S Adult Duo Mask and L2009 Clear View Adult Mask - Manufactured by Lifecare Hospital Supplies Ltd.
Specific lot numbers." | 14/02/2011 |
| Select | NICAS-350 | MDA-2011-013 | Alco-Prep alcohol skin preparation pads swabs and swabsticks | "Alco-Prep® alcohol skin preparation pads, swabs and swabsticks manufactured by H&W cv since 2007.
Also supplied in drug administration kits and needle exchange packs by :
• | 11/02/2011 |
| Select | NICAS-349 | MDA-2011-12R | GemStar pump sets manufactured by Hospira UK Ltd. Specific part numbers and lot numbers distributed | GemStar pump sets manufactured by Hospira UK Ltd. Specific part numbers and lot numbers distributed from November 2008 to June 2010 inclusive. Hospira has initiated a product recall due to the potential for under-delivery when these sets are used at flow rate settings of less than 10ml/hour. | 10/02/2011 |
| Select | NICAS-348 | MDA-2011-012 | GemStar pump sets manufactured by Hospira UK Ltd | "GemStar pump sets manufactured by Hospira UK Ltd. Specific part numbers and lot numbers distributed from November 2008 to June 2010 inclusive.
Hospira has initiated a product recall due to the potential for under-delivery when these sets are used at flow rate settings of less than 10ml/hour.
Hospira has initiated a product recall due to the potential for under-delivery when these sets are used at flow rate settings of less than 10ml/hour." | 09/02/2011 |
| Select | NICAS-347 | MDA-2011-011 | Blood glucose meters for professional use only: Accu-Chek Inform and Inform II manufactured by Roche | Blood glucose meters for professional use only: Accu-Chek Inform and Inform II manufactured by Roche Diagnostics Limited. Units of measure may change from mmol/L to mg/dL, which could result in the meter user thinking that the blood glucose level is higher than it actually is. | 07/02/2011 |
| Select | NICAS-346 | MDA-2011-010 | All slings manufactured by The Helping Hand Company for use with patient hoists and standing aids. | "All slings manufactured by The Helping Hand Company for use with patient hoists and standing aids. The instructions for use did not include pre-use checks of the sling material and stitching to identify faulty or damaged slings. Users are at increased risk of a fall if slings are not adequately inspected.
The manufacturer issued a Field Safety Notice incorporating revised instructions for use in October 2010 but has not been able to trace all users.
The cleaning instructions have also been improved." | 03/02/2011 |
| Select | NICAS-344 | MDA-2011-008 | All T-Series shower chairs with drop-down armrests | "All T-Series shower chairs with drop-down armrests - Manufactured by Freeway Healthcare (a division of Prism Medical UK).
The backrest frame is not strong enough for the claimed maximum user weight of 200kg. There is potential for the armrest to fail during use, resulting in the person falling and suffering serious injury." | 24/01/2011 |
| Select | NICAS-345 | MDA-2011-009 | Mobile operating tables manufactured by Maquet – mains power lead | "Mobile operating tables manufactured by Maquet – mains power lead. Models Alphaclassic, Alphastar, Betastar and Alphamaxx series.
Some leads supplied with these tables have been incorrectly manufactured and have an opening for a protective earth pin, although there is no connection to the attached mains plug.
Using the lead with another device or item of electrical equipment that requires a protective earth presents a risk of electric shock, should an electrical fault occur." | 24/01/2011 |
| Select | NICAS-343 | MDA-2011-007 | 5ml Plastipak Luer-Lok tip sterile syringe manufactured by Becton Dickinson (BD). BD product code 30 | "5ml Plastipak Luer-Lok tip sterilesyringe manufactured by Becton Dickinson (BD). BD product code 300911 - lot Number 10E05F only. The unit pack in this specific lot may not have a complete seal and so the syringe may not be sterile.
There is a risk of infection if the non-sterile
syringe is used." | 20/01/2011 |
| Select | NICAS-342 | MDA-2011-006 | Oxford patient hoist weigh scales | "Oxford patient hoist weigh scales - part no OP97000, supplied by Sunrise Medical or Joerns Healthcare between July 1997 and April 2003.
These weigh scales may detach from the hoist during a lifting operation, resulting in serious injury to the occupant or others." | 19/01/2011 |
| Select | NICAS-340 | MDA-2011-004 | Counterfeit Covidien Nellcor SpO2 Durasensor® (DS-100A) sensors. | "Counterfeit Covidien Nellcor SpO2 Durasensor® (DS-100A) sensors. Counterfeit Nellcor SpO2 Durasensor (DS-100A) may have been supplied to hospitals and clinics. Covidien, the legitimate manufacturer, has found that sample counterfeit devices partially failed to provide SpO2 readings when tested
with OxiMaxTM/Nellcor monitors." | 18/01/2011 |
| Select | NICAS-341 | MDA-2011-005 | Stemmed tibial broach impactor and rotating hinge tibial broach impactor | "Orthopaedic instruments.
Stemmed tibial broach impactor and rotating hinge tibial broach impactor used in the Zimmer NexGen complete knee solution instrumentation set.
There is a potential for the thumb pin to detach from the device during impact (see figure 1).
If left in the surgical site it can migrate into the intra-articular space, cause soft tissue irritation and interfere with magnetic resonance imaging (MRI) procedures." | 18/01/2011 |
| Select | NICAS-337 | MDA-2011-002 | Peristeen Anal Irrigation System manufactured by Coloplast Limited. | "Peristeen Anal Irrigation System manufactured by Coloplast Limited. Bowel perforation is an extremely rare (less
than 1 in 100,000 uses) complication to anal irrigation. Recently, there have been some incidents of bowel perforation following insertion of the rectal catheter, which is part of the anal irrigation system." | 06/01/2011 |
| Select | NICAS-338 | MDA-2011-003 | Nasogastric feeding tube.Feeding tube with male Luer lock. Manufactured by Unomedical. Sizes: 4Fr, 5 | Nasogastric feeding tube.Feeding tube with male Luer lock. Manufactured by Unomedical. Sizes: 4Fr, 5Fr, 6Fr, 8 Fr and 10Fr. Specific lot numbers. Luer lock connector may crack due to moulding problem. This can result in inadequate treatment due to leakage and a risk of choking if fragments of the connector become loose. | 06/01/2011 |
| Select | NICAS-336 | MDA-2011-001(NI) | Reporting Adverse Incidents on Medical Devices. | "Reporting Adverse Incidents on Medical Devices.
Growing levels of reporting of medical device related adverse incidents by the manufacturers to the Medicines and Healthcare products Regulatory Agency’s Adverse Incident Centre are not being reflected by the number of reported incidents coming from the user and the healthcare environment." | 04/01/2011 |
| Select | NICAS-333 | MDA-2010-097 | X-ray detectable gauze swabs manufactured by Rocialle | "X-ray detectable gauze swabs manufactured by Rocialle.
Rocialle is recalling specific batch numbers of X-ray detectable gauze swabs." | 20/12/2010 |
| Select | NICAS-334 | MDA-2010-098 | Defibrillator monitor | "Defibrillator monitor PIC 50 manufactured by Welch Allyn serviced under contract by Zoll UK.
Failure of the display screen, which prevents viewing of ECG and other vital signs." | 20/12/2010 |
| Select | NICAS-331 | MDA-2010-095 | Implantable cardioverter defibrillator (ICD) leads - Riata and Riata ST – all models - Manufactured | "Implantable cardioverter defibrillator (ICD) leads - Riata and Riata ST – all models - Manufactured by St Jude Medical.
Risk of inappropriate therapy due to wear and/or abrasion of lead insulation." | 16/12/2010 |
| Select | NICAS-332 | MDA-2010-096 | Paediatric tracheostomy tubes - All Shiley paediatric models and sizes manufactured by Corvidien | "All Shiley paediatric models and sizes manufactured by Corvidien.
The MHRA is aware of an increase in failure rate of paediatric Shiley tracheostomy tubes, based on reports received between 2008 and 2010." | 16/12/2010 |
| Select | NICAS-330 | MDA-2010-091R | Linear accelerator C-Series Clinacs manufactured by Varian Medical Systems Inc | "Linear accelerator C-Series Clinacs manufactured by Varian Medical
Systems Inc. Amendment: an additional model number has been added:
Models H14, H18, H27, H29." | 15/12/2010 |
| Select | NICAS-329 | MDA-2010-094 | Umbilical cord clamps – all makes and models | "Umbilical cord clamps – all makes and models.
Incorrect placement of the clamp on the umbilical cord has lead to an inadequate seal and blood loss in a small number of cases. Such blood loss could prove fatal for some babies." | 14/12/2010 |
| Select | NICAS-328 | EFA-2010-012 | Toffeln Qwirki's 800 Crocs Style Clogs sold as Personal Protective Equipment | Toffeln Qwirki’s 800 Crocs Style Clogs sold as Personal Protective Equipment (PPE) may not provide protection against penetration by sharp objects through the sole. | 13/12/2010 |
| Select | NICAS-327 | MDA-2010-093 | Contact lenses. 1 Day Acuvue TruEye (narafilicon A). Manufactured by Johnson & Johnson Vision Care ( | "Contact lenses. 1 Day Acuvue TruEye (narafilicon A). Manufactured by Johnson & Johnson Vision Care (Ireland). Lot numbers with the first six digits within the ranges 492237 to 492498 inclusive and 502080 to 502269 inclusive.
Recall of specific product.
Lenses from affected lots can cause stinging or pain upon insertion because of higher than expected levels of decanoic acid." | 01/12/2010 |
| Select | NICAS-325 | MDA-2010-091 | Linear accelerator C-Series Clinacs manufactured by Varian Medical Systems Inc. Models H14, H18, H29 | Linear accelerator C-Series Clinacs manufactured by Varian Medical Systems Inc. Models H14, H18, H29. The collimator cover can become loose and fall on to the patient during treatment. It is possible to install the cover incorrectly, but still fasten the latching mechanism: this leaves the potential for the cover to fall off. | 30/11/2010 |
| Select | NICAS-326 | MDA-2010-092 | All Oxylog 3000 emergency/transport ventilators. Manufactured by Draeger. | "All Oxylog 3000 emergency/transport ventilators. Manufactured by Draeger. Insufficient ventilation of paediatric patients
when using small tidal volumes (50 -100 ml). This problem can result in gas being re-breathed and a potential dangerous rise in CO2." | 30/11/2010 |
| Select | NICAS-323 | MDA-2010-090 | Patient vital signs monitor.Models M3002 IntelliVue X2 and M8102A IntelliVue MP2 manufactured by Phi | Patient vital signs monitor.Models M3002 IntelliVue X2 and M8102A IntelliVue MP2 manufactured by PhilipsHealthcare. Affected serial numbers X2: DE83629383—DE95052110 inclusive MP2: DE83604981—DE95008299 inclusive. The loud speakers on Philips IntelliVue X2 and MP2 monitors can fail. This may delay the recognition of critical clinical signs, delaying the patient’s treatment. | 24/11/2010 |
| Select | NICAS-321 | MDA-2010-089 | Level 1® normothermic IV fluid administration sets for use with fast flow fluid warming units manufa | "Level 1® normothermic IV fluid administration sets for use with fast flow fluid warming units manufactured by Smiths Medical. Product codes D-60HL and DI-60HL. Specific lots.
This disposable IV fluid administration set has a heat exchanger assembly that may be too long.
The set may not fit into Level 1® fast flow fluid warmers making the set unusable. This could delay treatment while another disposable set or an alternative method of fluid warming is obtained." | 18/11/2010 |
| Select | NICAS-320 | MDA-2010-088 | Uterine sounds.Manufactured by Rocket Medical plc.Model number R57420, lot 416163. | "Uterine sounds.Manufactured by Rocket Medical plc.Model number R57420, lot 416163. Model number R60547, lots 416367 and 416818. Incorrect moulding of uterine sound stem has resulted in a shorter length device.
The uterine sound will not function correctly with a missing distal tip and the condition of the stem could cause injury." | 17/11/2010 |
| Select | NICAS-319 | MDA-2010-087 | Siemens e-cam gamma camera | "Siemens e-cam gamma camera
The MHRA is aware of an incident in which a patient was injured (finger amputation) during movement of the gamma camera couch (patient handling system)." | 04/11/2010 |
| Select | NICAS-318 | MDA-2010-086 | All XLT manual wheelchairs with a backrest height of less than 40cm. Manufactured by Invacare. | "All XLT manual wheelchairs with a backrest height of less than 40cm. Manufactured by Invacare. XLT wheelchairs with a backrest height of less than 40cm are not suitable for use as a seat in a vehicle. Occupants will be at increased risk of injury in the event of a vehicle impact. Invacare has issued a Field Safety Notice (FSN031) with warning labels to be affixed to each wheelchair but have been unable to trace
all users." | 03/11/2010 |
| Select | NICAS-317 | MDA-2010-085 | All Oxford Midi 150A electrical hoists manufactured by Sunrise Medical before December 2005 | All Oxford Midi 150A electrical hoists manufactured by Sunrise Medical before December 2005. There is the potential for the hoist to fail during lifting resulting in serious injury to the occupant or others. | 28/10/2010 |
| Select | NICAS-316 | MDA-2010-084 | Disposable coring bone trephine and disposable dowel harvest tube. Manufactured by Biomet Sports Med | "Disposable coring bone trephine and disposable dowel harvest tube. Manufactured by Biomet Sports Medical.
The manufacturer is recalling specific lots of
disposable coring trephine and dowel harvesting tubes used for autogenous bone procedures. These devices are fitted with end caps that may leave a residue on the instruments or discolour them. Currently, it is not known if this residue will have any adverse effect on patients. This is being investigated and further information will be provided if appropriate." | 27/10/2010 |
| Select | NICAS-315 | MDA-2010-083 | Specific models and serial numbers of Contoura 800 series beds manufactured by Huntleigh Healthcare | "Specific models and serial numbers of Contoura 800 series beds manufactured by Huntleigh Healthcare Ltd. The manual operating system for the emergency cardiopulmonary resuscitation (CPR) function might fail. ArjoHuntleigh has issued a Field Safety Notice detailing the specific areas to be examined, but
has been unable to trace all affected beds." | 25/10/2010 |
| Select | NICAS-314 | MDA-2010-082 | Haemodialysis bloodlines: 5008/5008S, 4008 E-beam and 4008 ETO. Manufactured by Fresenius Medical Ca | "Haemodialysis bloodlines: 5008/5008S, 4008 E-beam and 4008 ETO. Manufactured by Fresenius Medical Care AG & Co KGaA. Specific product codes. Due to a change in material used in the manufacture of Fresenius Medical Care bloodline connectors, it may be difficult to
connect them to other manufacturers’ dialysers. There is an increased risk of haemolysis and blood leakage occurring." | 20/10/2010 |
| Select | NICAS-311 | MDA-2010-081 | Ambulance trolley. Model 6100 M1 manufactured by Stryker. Affected serial numbers: 001239066 – 09113 | "Ambulance trolley. Model 6100 M1 manufactured by Stryker. Affected serial numbers: 001239066 – 091139098 inclusive. Components of the head end of the trolley can break during use which may cause the head end to collapse. This has the potential to injure patients and staff
and/or delay treatment of the patient." | 14/10/2010 |
| Select | NICAS-310 | MDA-2010-080 | Atlantic bed rails.Product code EBA013. Manufactured by Park House Healthcare Ltd. | "Atlantic bed rails.Product code EBA013. Manufactured by Park House Healthcare Ltd. The original instructions for use issued with these bed rails contained insufficient information for correct installation. If incorrectly fitted there is a risk of entrapment between the bed rail and
the head or foot board of the bed, resulting in postural asphyxiation." | 12/10/2010 |
| Select | NICAS-309 | MDA-2010-079 | Smart Chargers for Neptune, Aquila and Splash bath lifts and for Mountway Solo toilet lifts. | Smart Chargers for Neptune, Aquila and Splash bath lifts and for Mountway Solo toilet lifts. The three-pin mains plugs fitted to some of these smart battery chargers do not meet the requirements of BS 1363-1 in body, pin and fuse construction and are potentially unsafe. | 11/10/2010 |
| Select | NICAS-307 | MDA-2010-077 | Contact lenses.Softperm (synergicon A) daily wear.Manufactured by Ciba Vision Corporation. | "Contact lenses.Softperm (synergicon A) daily wear.Manufactured by Ciba Vision Corporation. Recall of specific product.
Product may cause eye infections and/or
burning and stinging upon initial insertion of the lens." | 04/10/2010 |
| Select | NICAS-306 | MDA-2010-076 | SleepStyle CPAP devices. Manufactured by Fisher & Paykel Healthcare. Specific model and lot numbers | SleepStyle CPAP devices.Manufactured by Fisher & Paykel Healthcare. Specific model and lot numbers are affected. Risk of cessation of therapy due to deterioration of power cord. | 29/09/2010 |
| Select | NICAS-305 | MDA-2010-075 | All Ventnor mobile shower chairs manufactured by James Spencer & Co Ltd. | All Ventnor mobile shower chairs manufactured by James Spencer & Co Ltd. Due to inadequate maintenance instructions, castors may loosen and detach, causing the user to fall from the chair. | 28/09/2010 |
| Select | NICAS-304 | MDA-2010-074 | Patient vital signs monitor: Delta and Gamma XXL manufactured by Draeger Medical. | "Patient vital signs monitor: Delta and Gamma XXL manufactured by Draeger Medical. The keypad can become inoperative or activate unintentionally, which may result in a treatment
delay. Affected units were manufactured from March 2008 to April 2009 inclusive." | 21/09/2010 |
| Select | NICAS-302 | MDA-2010-072 | Vascular catheters:K-Flow Access Catheters.Kimal High Flow (HF) Haemodialysis Catheters.Kimal Right | "Vascular catheters:K-Flow Access Catheters.Kimal High Flow (HF) Haemodialysis Catheters.Kimal Right Atrial (KRA) Catheters.Manufactured by Kimal.Devices with specific product codes and expiry dates are affected.
The CE marking of these specific catheters is invalid.
The safety and performance of these devices has not been submitted for independent assessment." | 16/09/2010 |
| Select | NICAS-301 | MDA-2010-071 | Tracheostomy dressing. Manufactured by Kapitex Healthcare Ltd. Trachi-Dress TR DRE 0001. | "Tracheostomy dressing. Manufactured by Kapitex Healthcare Ltd. Trachi-Dress TR DRE 0001. Lots: WO 25700 – WO 25702.
Supplied in the UK from 28/07/09 to 11/01/10. The dressing material may have poor lamination, primarily on the shiny side (patient contact side). It may de-laminate in use over time with the possibility of viscose fibres detaching and entering the tracheal stoma." | 13/09/2010 |
| Select | NICAS-300 | MDA-2010-070 | LIFEPAK 20-20e | "LIFEPAK 20-20e defibrillator/monitor.
Manufactured by Medtronic/Physio-Control. Specific serial numbers are affected.
Due to component failures, which affect AC (mains) and/or DC (battery) operating power, there is a risk that the defibrillator will not deliver therapy.
The corrective action programme initiated by the manufacturer will take approximately two years to complete." | 09/09/2010 |
| Select | NICAS-299 | MDA-2010-069 | DePuy ASR™ hip replacement implants | DePuy ASR™ hip replacement implants. Recall of ASR hip replacement implants due to increased rates of revision. | 07/09/2010 |
| Select | NICAS-298 | MDA-2010-068 | IV extension sets with multiple ports and vented caps. Various manufacturers. | IV extension sets with multiple ports and vented caps. Various manufacturers. Risk of air embolism and death. | 06/09/2010 |
| Select | NICAS-297 | MDA-2010-067 | Contact lens solution. AMO Complete® multi-purpose solution. | Contact lens solution. AMO Complete® multi-purpose solution. Manufactured by Abbott Medical Optics Inc (AMO). Recall of specific product lot numbers. Sterility of the product may be compromised due to poor fitting caps. | 26/08/2010 |
| Select | NICAS-296 | MDA-2010-066 | Neurosurgical sponges (patties). Manufactured by Codman. | "Neurosurgical sponges (patties). Manufactured by Codman. Product code: 80-1396 and 80-1399. Specific lots (see manufacturer’s Field Safety Notice). Radiopaque strips may be retained in patients. Codman is recalling surgical sponges (patties) from certain lots (distributed from May 2009 to May 2010 inclusive) because affected products
were manufactured with reduced adhesion
between the sponges and the blue radiopaque strip. This may result in the strip becoming detached during surgery." | 19/08/2010 |
| Select | NICAS-295 | MDA-2010-065 | Suction liners. Receptal 1, 1.5 and 2 litre PVC liners. | "Suction liners. Receptal 1, 1.5 and 2 litre PVC liners. Manufactured by Hospira (formerly manufactured by Abbott). Due to a manufacturing fault, the lid of Receptal
PVC suction liners may not be correctly aligned. When fitted to the suction canister this can result in an inadequate seal and loss of suction. To date, up to 10% of the affected suction liners have exhibited misaligned lids." | 16/08/2010 |
| Select | NICAS-293 | MDA-2010-063 | T-Bag oxygen enrichment device: 7000T. Manufactured by Ultimate Medical Pty Ltd. Distributed in the | "T-Bag oxygen enrichment device: 7000T.
Manufactured by Ultimate Medical Pty Ltd.
Distributed in the UK by Intavent Direct. All devices supplied prior to February 2010
are affected. Possible occlusion of T-Bag oxygen enrichment device by a plastic membrane which is caused by a moulding fault during manufacture. This fault
could prevent or restrict the gas flow to the patient." | 05/08/2010 |
| Select | NICAS-292 | MDA-2010-062 | Processing AT1 set (item no. 9005101) used with the CATS® continuous autotransfusion system. | Processing AT1 set (item no. 9005101) used with the CATS® continuous autotransfusion system. Manufactured by Fresenius Kabi. Sets manufactured between January 2009 and April 2010 are affected. A manufacturing problem has been identified with these sets which can result in failure to prime. This may then require a manual intervention to allow the process to continue. This can cause interruption to therapy. | 02/08/2010 |
| Select | NICAS-290 | MDA-2010-061 | EEG recorder: NicoletOne® System. Manufactured by CareFusion 209 Inc, formerly Viasys Healthcare Inc | "EEG recorder: NicoletOne® System. Manufactured by CareFusion 209 Inc, formerly Viasys Healthcare Inc. Software versions 5.3, 5.4 and 5.7.
The standard NicoletOne System has a left/right (L/R) headbox configuration. However, NicoletOne Systems with software versions 5.3, 5.4, and 5.7 also have right/left (R/L) headbox configurations. There is potential for misinterpretation of EEG results when using the R/L configurations." | 20/07/2010 |
| Select | NICAS-289 | MDA-2010-060 | Sigmoidoscope and anoscope systems and accessories manufactured by Welch Allyn Limited. Endoscopes u | Sigmoidoscope and anoscope systems and accessories manufactured by Welch Allyn Limited. Endoscopes used for the examination of the large intestine and rectum. Potential cross-contamination from inadequate decontamination of reusable insufflation bulb and light head accessories. | 15/07/2010 |
| Select | NICAS-286 | MDA-2010-058 | GE Healthcare Anaesthetic CareStations. Models: Aespire 100/7100, Aespire 7900, Aespire View, Avance | GE Healthcare Anaesthetic CareStations. Models: Aespire 100/7100, Aespire 7900, Aespire View, Avance, Amingo, ADS 180. The O2 flush button can become impeded by the work surface of the care station and stick in the open or partially open position, resulting in flow of O2 into the breathing system. This may cause dilution of anaesthetic agent or barotrauma. | 06/07/2010 |
| Select | NICAS-287 | MDA-2010-059 | Linear accelerator system - C-Series Clinacs manufactured by Varian Medical Systems Inc - Models H14 | "Linear accelerator system - C-Series Clinacs manufactured by Varian Medical Systems Inc - Models H14, H27, H29 and HCX.
A collision between the gantry and the patient may occur if a patient previously treated using a C-Series Clinac running version 6.X software is then treated using a C-Series Clinac running version 7.X software." | 06/07/2010 |
| Select | NICAS-285 | MDA-2010-057 | Alvema ITO pushchair for disabled children | "Alvema ITO pushchair for disabled children manufactured by Eurovema AB and supplied in the UK by Rainbow Mobility Ltd.
This includes:
ITO Small with serial numbers from 104709 to 105306 inclusive ITO Large with serial numbers from 104009 to 106789 inclusive.
The frame tubes can break causing the pushchair to tip and injure the occupant or carer." | 30/06/2010 |
| Select | NICAS-283 | MDA-2010-055 | TruSat Pulse Oximeter manufactured by GE Healthcare | "TruSat Pulse Oximeter manufactured by GE Healthcare (formerly Datex-Ohmeda). Part numbers: 605100000-190, 605100000-191,
605100000-192, 605100000-193. Possibility of excessive leakage current
resulting in abnormal heart rhythm or burns. There is a potential electrical safety risk to the user when the device is running on the external power supply and the power supply connector is damaged or improperly connected on the TruSat.
The manufacturer published a Field Safety
Notice covering this issue on 2 June 2010, but has not received confirmation of its receipt from all customers." | 29/06/2010 |
| Select | NICAS-284 | MDA-2010-056 | Welch Allyn CP200 Electrocardiograph | "Welch Allyn CP200 Electrocardiograph. When using the CP 200 in Auto ECG and Stat ECG modes, it is possible to print a previous patient’s ECG (without patient identifier) if the Auto ECG Post-Print screen is not exited properly in accordance with the manufacturer’s instructions.
Consequently, there is a risk of patients
receiving the wrong ECG report leading to
misdiagnosis and incorrect treatment." | 29/06/2010 |
| Select | NICAS-280 | MDA-2010-052 | Anaesthetic vaporizers used to administer volatile agents for the maintenance of anaesthesia - all m | "Anaesthetic vaporizers used to administer volatile agents for the maintenance of anaesthesia - all manufacturers.
The MHRA has received reports where the failure to correctly attach vaporizers to the anaesthetic machine backbar has led to anaesthetic gas leakage and patient awareness." | 28/06/2010 |
| Select | NICAS-281 | MDA-2010-053 | All 5008 & 5008S Haemodialysis Machines manufactured before August 2008. | "All 5008 & 5008S Haemodialysis Machines manufactured before August 2008. Manufactured by Fresenius Medical Care AG & Co. KGaA. An electronic component may fail and cause the visual screen display of the haemodialysis machine to ‘black out’. The touch screen may
still remain active/touch sensitive despite the visual screen failure. Smoke may also be released from the screen." | 28/06/2010 |
| Select | NICAS-279 | MDA-2010-051 | Appollo bath hoists. Models: Elegance, Excalibur and Appollo. Manufactured by Reva Industries Ltd | Appollo bath hoists. Models: Elegance, Excalibur and Appollo. Manufactured by Reva Industries Ltd previously manufactured by Aquabeau or Airbath Appollo. There is a risk of the occupant sliding out of the seat and sustaining serious injury. | 21/06/2010 |
| Select | NICAS-278 | MDA-2010-050 | Implantable vagus nerve stimulators (VNS) | "Implantable vagus nerve stimulators (VNS):
• | 16/06/2010 |
| Select | NICAS-277 | MDA-2010-049 | Liftmaster 160 and 190 electrical hoist manufactured by Patterson Medical Ltd | "Liftmaster 160 and 190 electrical hoist manufactured by Patterson Medical Ltd (formerly Homecraft Rolyan Ltd and Smith & Nephew Homecraft Ltd) with boom and
spreader bar assembly serial numbers
SN4000001 to SN4001999 inclusive." | 15/06/2010 |
| Select | NICAS-276 | MDA-2010-048 | Hepatitis C virus total antibody kit. ARCHITECT anti-HCV manufactured by Abbott GmbH & Co. KG | Hepatitis C virus total antibody kit ARCHITECT anti-HCV manufactured by Abbott GmbH & Co. KG. Rare potential for false negative HCV result which may lead to a missed diagnosis of hepatitis C infection. | 10/06/2010 |
| Select | NICAS-273 | MDA-2010-046 | Unilect ECG monitoring electrodes manufacturerd by Unomedical | "Unilect ECG monitoring electrodes manufacturerd by Unomedical (A ConvaTec Company). Specific product and lot numbers.
The gel on the affected ECG monitoring electrodes may migrate. The manufacturer is recalling affected devices" | 02/06/2010 |
| Select | NICAS-274 | MDA-2010-047 | Ondal Acrobat 2000 (AC2000) spring arm used to support operating lights and monitors made by various | "Ondal Acrobat 2000 (AC2000) spring arm used to support operating lights and monitors made by various manufacturers. Specific serial numbers. There is the potential for metal fatigue fractures on the front joint of the spring arm to occur over time. There is an internal cable which will usually support the light or monitor if the arm fractures, but the cable could break and cause injury to the patient and staff.
Ondal has issued guidance to the manufacturers that use these spring arms. Users should have been informed of this by their respective equipment supplier. A non-exhaustive list is attached.
Users need to check the swing arm to establish if it has an Ondal label." | 02/06/2010 |
| Select | NICAS-271 | MDA-2010-045 | Handle assembly fitted to monkey pole, model TGN-R100R, manufactured by Rolko GmbH | "Handle assembly fitted to monkey pole, model TGN-R100R, manufactured by Rolko GmbH. Supplied in the UK by Hill-Rom from January 2007 to January 2009 inclusive. The height adjuster can fail in use, resulting in the strap extending and the handle dropping. This may cause the patient to fall and sustain an injury. Hill-Rom has issued a Field Safety Notice but
has been unable to trace all affected handle assemblies." | 27/05/2010 |
| Select | NICAS-270 | MDA-2010-044 | DePuy ASR TM acetabular cups used in hip resurfacing arthroplasty | DePuy ASR TM acetabular cups used in hip resurfacing arthroplasty and total hip replacement. The MHRA has received reports of higher than anticipated rates of revision for ASRTM acetabular cups. | 25/05/2010 |
| Select | NICAS-269 | MDA-2010-043 | Diathermy (electrosurgical) cables.Manufactured by Unomedical (a ConvaTec company).Product codes 340 | "Diathermy (electrosurgical cables. Manufactured by Unomedical (a ConvaTec company). Product codes 3405M and 3508M. Specific batches.
Certain batches of cables, used to connect Unomedical electrosurgical instruments to generators, have been supplied in mislabelled boxes.
Boxes labelled with the code 3508M may contain a cable with the code 3405M, or vice versa. The two cables have different sized and shaped connectors and therefore cannot be used interchangeably.
The cables can be readily distinguished from each other because they are colour coded:
• | 20/05/2010 |
| Select | NICAS-268 | MDA-2010-042 | Therapy chair manufactured by Pronefro SA and supplied in the UK by Hymed Healthcare Products Ltd | "Therapy chair manufactured by Pronefro SA and supplied in the UK by Hymed Healthcare Products Ltd.
The bracket securing the armrest can bend or break when an occupant applies their bodyweight to the armrest. This can lead to the occupant falling and sustaining serious injury." | 18/05/2010 |
| Select | NICAS-267 | MDA-2010-041 | Visionary single-use laryngeal airway device manufactured by by Marshall | "Visionary single-use laryngeal airway device (LAD) manufactured by by Marshall.
There is the potential for the LAD connector to break when attached to other devices. This can cause patient ventilation to be interrupted until the airway is replaced." | 17/05/2010 |
| Select | NICAS-266 | MDA-2010-040 | All chest drains when used with high-flow, low-vacuum suction | "All chest drains when used with high-flow, low-vacuum suction systems (wall mounted). Direct connection between the chest drain bottle and the wall mounted, high-flow, low vacuum regulator without an intermediate jar or canister can lead to:
• patient injury
• loss of effective suction
• contamination of the hospital vacuum
system and infection hazard." | 13/05/2010 |
| Select | NICAS-264 | MDA-2010-038 | X-ray detectable gauze swabs.RML122-044 10 cm x 7.5 cm 32ply. Manufactured by Rocialle. | X-ray detectable gauze swabs.RML122-044 10 cm x 7.5 cm 32ply. Lot number 090901. Manufactured by Rocialle. NHS Supply Chain Code: EM1235. Rocialle is recalling swabs from lot number 090901, which have been manufactured in two parts. If unfolded and opened out completely only one part of the swab has an X-ray detectable strip attached. Therefore, if the part of the swab without this strip is left inside the patient, it will not be detectable by X-ray examination. | 12/05/2010 |
| Select | NICAS-263 | MDA-2010-037 | Adult&paediatric Homechoice and Homechoice Pro automated system Manufactured by Baxter Healthcare Lt | "Peritoneal dialysis - Adult/paediatric Homechoice and Homechoice Pro automated system. Manufactured by Baxter Healthcare Ltd.
Reports of patients experiencing overfilling of intra-peritoneal fluid (also referred to as increased intra-peritoneal volume or IIPV) arising from inappropriate programming of prescription parameters." | 11/05/2010 |
| Select | NICAS-261 | MDA-2010-035 | Angiography X-ray system - AXIOM Artis systems with Polydoros A100 generators manufactured by Siemen | "Angiography X-ray system - AXIOM Artis systems with Polydoros A100 generators manufactured by Siemens Healthcare.
The system may fail to expose as a result of a contact problem at the low voltage power supply of the generator controller. This may occur spontaneously and may not be foreseeable." | 05/05/2010 |
| Select | NICAS-260 | MDA-2010-034 | Alaris GP and Alaris GP Guardrails volumetric pump with Plus software Manufactured by CareFusion, br | "Alaris GP and Alaris GP Guardrails volumetric pump with Plus software. Manufactured by CareFusion, branded as
Cardinal Health. Models 9002MED01 and 9002MED01-G. Software version 2.1.12. Due to a software irregularity, if the previous set up is not cleared at start-up, the single bubble detection threshold will default to 100 microlitres, without any
indication to the user. If the desired setting is less than 100 microlitres, there is the potential for serious injury, particularly to neonates. If the desired setting is greater than 100 microlitres, there is the potential for an increase in nuisance
alarms." | 27/04/2010 |
| Select | NICAS-259 | MDA-2010-033 | All metal-on-metal (MoM) hip replacements. | All metal-on-metal (MoM) hip replacements. The MHRA has received reports of revisions of MoM hip replacements involving soft tissue reactions. These reactions may be associated with unexplained hip pain. | 22/04/2010 |
| Select | NICAS-257 | MDA-2010-031 | Arcoma ArcoTable NT for use with X-ray systems | "Arcoma ArcoTable NT for use with X-ray systems.
Unexpected collapse of the table support columns may lead to patient or staff injury." | 20/04/2010 |
| Select | NICAS-258 | MDA-2010-032 | Shiley cuffed tracheostomy tubes - Manufactured by Covidien (formerly Tyco Healthcare) - Specific lo | "Shiley cuffed tracheostomy tubes - Manufactured by Covidien (formerly Tyco Healthcare) - Specific lot numbers.
Slow cuff deflation, which can result in aspiration or inadequate ventilation.
Covidien is recalling affected devices." | 20/04/2010 |
| Select | NICAS-256 | MDA-2010-030 | Blood glucose meters.5-second CONTOUR® manufactured by Bayer Diabetes Care. | "Blood glucose meters. 5-second CONTOUR® manufactured
by Bayer Diabetes Care. Affected devices may show falsely high
readings when testing samples from
neonates. Hypoglycaemia may go
undiagnosed as a result." | 15/04/2010 |
| Select | NICAS-254 | MDA-2010-028 | Enteral feeding administration sets. Applix Smart pump sets. Manufactured by Fresenius Kabi. | Enteral feeding administration sets. Applix Smart pump sets. Manufactured by Fresenius Kabi. Risk of non-delivery of enteral feed. Due to a manufacturing problem, the antifree flow clamp may not automatically open when the set is inserted into the enteral feed pump and its door is closed. The manufacturer has issued a Field Safety Notice, but omitted to include actions to be taken when priming the set by gravity. | 14/04/2010 |
| Select | NICAS-255 | MDA-2010-029 | Mobile hoists. Arjo Minstrel standard type HMA001 and EPC type HMA0011 manufactured by Medibo Medica | "Mobile hoists. Arjo Minstrel standard type HMA001 and EPC type HMA0011 manufactured by Medibo Medical NV. Inaccurate maintenance instructions and poor inspection of hanger bar attachment.
Attachments have failed in use leading to a fall and injury to the person being moved." | 14/04/2010 |
| Select | NICAS-250 | EFA-2010-005 | TASKI – Ergodisc Duo Type 43LHSL machine for wet scrubbing / stripping / buffing floors, manufacture | "TASKI – Ergodisc Duo Type 43LHSL machine for wet scrubbing / stripping / buffing floors, manufactured by Diversey Ltd.
There is a risk of switch failure, meaning that the machine cannot be switched off with the hand levers and has to be disconnected from mains to stop it.
When next used, a faulty machine will start immediately on being ‘plugged in’, resulting in uncontrolled operation and risk of injury / damage to anyone / anything in the near vicinity.
The TASKI machines have been used in the UK for some 20 years. The manufacturer has advised that this problem has so far only been observed on older machines which have been in regularly daily use." | 08/04/2010 |
| Select | NICAS-251 | MDA-2010-026 | PediCap 6 paediatric end-tidal CO2 detector manufactured by Covidien (part of Tyco Healthcare). Spec | "PediCap 6 paediatric end-tidal CO2 detector manufactured by Covidien (part of Tyco Healthcare). Specific lot numbers.
A modification to the indicator paper in the detector may result in:
•increased resistance to airflow
•inadequate sensing of carbon dioxide (CO2), as the indicator does not change colour
•delay in detection of an incorrectly placed breathing tube." | 08/04/2010 |
| Select | NICAS-252 | MDA-2010-027 | Endotracheal (ET) tubes, adult and paediatric sizes. Manufactured by Unomedical (a ConvaTec company | "Endotracheal (ET) tubes, adult and paediatric sizes. Manufactured by
Unomedical (a ConvaTec company). Risk of inadvertent disconnection of the endotracheal tube from the breathing system, interrupting patient ventilation until the tube is reconnected or replaced." | 08/04/2010 |
| Select | NICAS-249 | EFA-2010-004 | GN9120 wireless headset manufactured by GN Netcom Inc | "GN9120 wireless headset manufactured by GN Netcom Inc for use with professional telephony systems.
An internal short circuit in the Amperex Technology Ltd (ATL) lithium-ion polymer batteries, which was used in some of these devices, can cause the batteries to overheat, resulting in a risk of injury and/or fire.
Implicated batteries were sold from January 2005 to September 2008 as part of the headset and as a replacement part." | 07/04/2010 |
| Select | NICAS-245 | MDA-2010-023 | Intracranial stent: SILK artery reconstruction device manufactured by Balt Extrusion and distributed | Intracranial stent: SILK artery reconstruction device manufactured by Balt Extrusion and distributed in the UK by Pyramed Ltd. Potential for patient death if the device is used to treat intracranial aneurysms without using embolisation coils. | 23/03/2010 |
| Select | NICAS-246 | MDA-2010-024 | Endotracheal (ET) tubes, adult and paediatric sizes. | "Endotracheal (ET) tubes, adult and paediatric sizes.
Manufactured by Unomedical (a ConvaTec company).
Risk of inadvertent disconnection of the endotracheal tube from the breathing system, interrupting patient ventilation until the tube is reconnected or replaced." | 23/03/2010 |
| Select | NICAS-243 | EFA-2010-001a | MEDICAL PATIENT WEIGHING SCALES | Medical Patient Weighing Scales - used in healthcare premises may be inaccurate, inappropriate or not used correctly, leading to potential errors in diagnosis, treatment or medication of patients. | 16/03/2010 |
| Select | NICAS-242 | MDA-2010-022 | Hoists and standing aids - Manufactured by BHM Medical Inc | "Hoists and standing aids - Manufactured by BHM Medical Inc.
Models: Cricket-3, Cypress-2, Ergolift, Ergolift 600, Ergostand, Explorer, Explorer 600, Graduate, Junior, Medilifter-IV, Mezzo, Ministand, ML-4, Primo, Sherpa, SSL-2, Standup, Trekker and Xtreme.
Risk of electric shock when the hoist is connected to the mains supply with a single insulated power cable for battery charging." | 11/03/2010 |
| Select | NICAS-241 | MDA-2010-021 | Anaesthetic gas scavenging systems (AGSS). All manufacturers. | Anaesthetic gas scavenging systems (AGSS). All manufacturers. Risk of serious harm to the patient from excessive pressure in anaesthetic breathing systems caused by blockage of AGSS hoses. | 10/03/2010 |
| Select | NICAS-238 | MDA-2010-018 | All models of mobile hoists, ceiling hoists and bathing lifts manufactured by Joerns Healthcare Ltd. | "All models of mobile hoists, ceiling hoists and bathing lifts manufactured by Joerns Healthcare Ltd.
Lack of maintenance and inspection of these devices could lead to the occupant falling and being seriously injured." | 09/03/2010 |
| Select | NICAS-239 | MDA-2010-019 | All types of Oxford slings and standing harnesses manufactured by | "All types of Oxford slings and standing harnesses manufactured by
Joerns Healthcare Ltd for use with hoists and stand aids.
Unclear instructions for use.
The MHRA has received various incident reports where occupants have been injured as a result of incorrect use or inadequate inspections of slings before use." | 09/03/2010 |
| Select | NICAS-236 | MDA-2010-016 | Pregnancy test for professional use. Clearview hCG Combo manufactured by Unipath Limited. Product co | "Pregnancy test for professional use. Clearview hCG Combo manufactured by Unipath Limited. Product code 506760. False positive results may be observed when the test results are interpreted after:
• 3 minutes for urine samples
• 5 minutes for serum samples.
Specific product lot numbers contain
instructions for use that have since been
updated." | 08/03/2010 |
| Select | NICAS-237 | MDA-2010-017 | Peripheral cannula. Nexiva closed IV catheter system with Q-Syte connector | "Peripheral cannula. Nexiva closed IV catheter system with Q-Syte connector. Manufactured by Becton Dickinson.
The manufacturer has received reports of air entering into infusion lines through the
BD Q-Syte connector. Risk of air embolus to patients. This problem is an extension of the original action detailed in MDA/2009/075." | 08/03/2010 |
| Select | NICAS-235 | MDA-2010-015 | Powerheart AED G3 automatic external defibrillators (AEDs) manufactured by Cardiac Science Corporati | "Powerheart AED G3 automatic external defibrillators (AEDs) manufactured by Cardiac Science Corporation
Specific serial numbers.
Affected AEDs may fail to deliver a shock due to an internal short-circuit.
This is a separate problem to that described in MDA/2010/014 and a different range of serial numbers are affected." | 26/02/2010 |
| Select | NICAS-233 | MDA-2010-013A | Arjo Passive Clip sling and Arjo Passive Clip Flite slings | "Arjo Passive Clip sling and Arjo Passive Clip Flite slings manufactured by Medibo.
Incorrect attachment of the sling clips to the spreader bar. This can lead to the person in the sling falling out and injuring themselves or others." | 18/02/2010 |
| Select | NICAS-234 | MDA-2010-014 | Powerheart AED G3 and CardioVive automatic external defibrillators (AEDs) manufactured by Cardiac Sc | Powerheart AED G3 and CardioVive automatic external defibrillators (AEDs) manufactured by Cardiac Science Corporation. There is a small risk that the AED may not deliver a shock. The software self-test may not detect a fault with a specific internal component, so the AED may not be able to deliver a shock during a rescue attempt. | 18/02/2010 |
| Select | NICAS-232 | MDA-2010-012 | Teligen implantable cardioverter defibrillators (ICDs) and Cognis cardiac resynchronisation therapy | Teligen implantable cardioverter defibrillators (ICDs) and Cognis cardiac resynchronisation therapy defibrillators (CRT-Ds) – specific models. Manufactured by Boston Scientific. | 10/02/2010 |
| Select | NICAS-229 | MDA-2010-011 | Servo 300 and 900 ventilators (SV300 and SV900) manufactured by Siemens (now Maquet) | Servo 300 and 900 ventilators (SV300 and SV900) manufactured by Siemens (now Maquet) - Excessive negative pressures (e.g. using closed suction systems) can damage the inspiratory and expiratory pressure measurement transducers. Such damage has lead to high gas flows that subsequently caused bilateral pneumothoraces. | 08/02/2010 |
| Select | NICAS-228 | MDA-2010-010 | C-Max U/2 stair climbers manufactured by Alber Antriebstechnik GmbH (AAT) | "C-Max U/2 stair climbers manufactured by Alber Antriebstechnik GmbH (AAT) - There is a risk of injury to the attendant’s hand,
by the climbing mechanism, if the stair climber is activated when two people are moving it." | 01/02/2010 |
| Select | NICAS-227 | MDA-2010-009 | T-piece connector incorporated into various breathing systems. Manufactured by Intersurgical Ltd. | T-piece connector incorporated into various breathing systems. Manufactured by Intersurgical Ltd. Possible occlusion of the connector by a plastic membrane caused by a moulding fault during manufacture. This fault could prevent or restrict the gas flow to the patient. | 28/01/2010 |
| Select | NICAS-225 | MDA-2010-007 | All pole clamps for Infusomat Space and Perfusor Space infusion pumps. | "All pole clamps for Infusomat Space and Perfusor Space infusion pumps. Manufactured by B Braun.
Part number 8713130. If the manufacturer’s instructions for use are not
followed and the pole clamp components are damaged or missing following use, there is a risk of detachment of the infusion pump from the pole clamp with subsequent damage." | 19/01/2010 |
| Select | NICAS-223 | MDA-2010-005 | GE patient tables for use with GE X-ray systems (Proteus XR/a, Revolution XR/d and Definium 8000 sys | GE patient tables for use with GE X-ray systems (Proteus XR/a, Revolution XR/d and Definium 8000 systems) with table model numbers 2259988, 2259988-2, 2351505 and 5131070. Unexpected movement of the floating tabletop due to failure of the brake mechanism. There is a risk of injury as a patient may lose balance when getting on or off the table. | 13/01/2010 |
| Select | NICAS-221 | MDA-2010-004 | Action 3 and Action 4 manual wheelchairs manufactured by Invacare. | "Action 3 and Action 4 manual wheelchairs manufactured by Invacare.
Invacare has revised the instructions for use for various safety related aspects.
Users who are unaware of these revised instructions are at risk of injury. In particular, from a fall due to instability or from positional asphyxiation due to poor lap belt position, fitting or adjustment." | 11/01/2010 |
| Select | NICAS-220 | MDA-2010-003 | Universal cables for use with ConMed Linvatec surgical power tools - Device catalogue number MC5057 | "Universal cables for use with ConMed Linvatec surgical power tools - Device catalogue number MC5057 - Only cables manufactured before 01 December 2006 are affected.
There is a possibility that a worn or damaged power cable may cause the handpiece to self-activate.
ConMed Linvatec issued a Field Safety Notice on this problem in September 2009." | 05/01/2010 |
| Select | NICAS-218 | MDA-2010-001 | Medical devices in general and non-medical products. | "Medical devices in general and non-medical products.
Off-label use of medical devices.
User modifications of devices other than directed by the device manufacturer.
Use of products, other than those that are CE-marked as medical devices, for clinical purposes." | 04/01/2010 |
| Select | NICAS-216 | MDA(NI)2009-085 | GE Fluoro uninterruptible power supply units (UPS) 20KVA associated with Innova cardiovascular X-ray | "GE Fluoro uninterruptible power supply units (UPS) 20KVA associated with Innova cardiovascular X-ray imaging systems. The UPS battery can degrade and its life expectancy may be shortened, potentially causing the UPS to become unavailable.
This may result in sudden curtailment of examinations with serious consequences for patient diagnosis or treatment." | 18/12/2009 |
| Select | NICAS-214 | MDA(NI)2009-083 | MiniMed Paradigm Veo insulin pump manufactured by Medtronic. All serial numbers. | MiniMed Paradigm Veo insulin pump manufactured by Medtronic. All serial numbers. Two functions on this pump do not work correctly: wireless meter reading; missed bolus reminder. There is a potential for inappropriate insulin administration. | 16/12/2009 |
| Select | NICAS-215 | MDA(NI)2009-084 | LIFEPAK CR ® Plus automatic external defibrillator manufactured by Medtronic Physio-Control. Specifi | LIFEPAK CR ® Plus automatic external defibrillator manufactured by Medtronic Physio-Control. Specific serial numbers. Failure to deliver therapy. A faulty internal cable in defibrillators manufactured from November 2006 to March 2008 inclusive may prevent the defibrillator from switching on. The manufacturer has restarted their upgrade program and any outstanding devices should now receive the corrective action. | 16/12/2009 |
| Select | NICAS-212 | MDA(NI)2009-081 | Rea Azalea wheelchairs manufactured by Invacare Rea AB | Rea Azalea wheelchairs manufactured by Invacare Rea AB | 14/12/2009 |
| Select | NICAS-213 | MDA(NI)2009-082 | Birdie mobile hoists manufactured by Invacare. | Birdie mobile hoists manufactured by Invacare. The legs of the base can detach and cause the hoist to tip in use, leading to injury to the occupant or others. | 14/12/2009 |
| Select | NICAS-209 | MDA(NI)2009-078 | Intra-aortic balloon pump harness safety system supplied for use with | Intra-aortic balloon pump harness safety system supplied for use with the CS300 balloon pump. Supplied by Datascope, now Maquet. The harness was not designed to be used with the CS300 balloon pump and therefore does not adequately secure it during ambulance transportation. | 08/12/2009 |
| Select | NICAS-210 | MDA(NI)2009-079 | Martin Heavy Duty manual wheelchair manufactured by Karma Mobility Ltd. | Martin Heavy Duty manual wheelchair manufactured by Karma Mobility Ltd. The backrest can fail in use causing the occupant to fall from the wheelchair resulting in serious injury. | 08/12/2009 |
| Select | NICAS-208 | MDA(NI)2009-077 | X-ray detectable gauze swabs – sterile and non-sterile Swabx manufactured by Richardson Healthcare L | "X-ray detectable gauze swabs – sterile and non-sterile Swabx manufactured by Richardson Healthcare Limited. The X-ray filament within the swab is of insufficient tensile strength, which may cause the thread to fragment during use.
Richardson Healthcare is recalling specific lot numbers of Swabx X-ray detectable gauze swabs." | 25/11/2009 |
| Select | NICAS-206 | MDA(NI)2009-075 | Needle-free intravascular connectors: BD Q-Syte stand-alone Luer access split, BD Q-Syte with 15cm m | "Needle-free intravascular connectors:BD Q-Syte stand-alone Luer access split
septum connector, BD Q-Syte with 15cm micro bore extension set.Manufactured by Becton Dickinson. The manufacturer has received reports of air leaking into infusion lines through the BD Q-Syte connector.
Risk of air embolus to patients." | 18/11/2009 |
| Select | NICAS-205 | MDA(NI)2009-073R | Oxygen therapy.Multifit nebulizer and Multifit nebulizer with BOC adaptor. | "Oxygen therapy.Multifit nebulizer and Multifit nebulizer with BOC adaptor.
Failure to provide humidification due to a manufacturing defect. This could result in patients developing dry airways, causing discomfort and irritation.
The manufacturer is recalling specific batches. No other batch numbers are affected." | 13/11/2009 |
| Select | NICAS-204 | MDA(NI)2009-074 | Servo 300 and 900 ventilators (SV300 and SV900) manufactured by Siemens (now Maquet).Servo 300 and 9 | Servo 300 and 900 ventilators (SV300 and SV900) manufactured by Siemens (now Maquet). Very high gas flow may lead to bilateral pneumothoraces, due to the failure of the inspiratory and expiratory flow measurement transducers. | 12/11/2009 |
| Select | NICAS-203 | MDA(NI)2009-073 | Oxygen therapy.Multifit nebulizer and Multifit nebulizer withBOC adaptor. | "Oxygen therapy.Multifit nebulizer and Multifit nebulizer withBOC adaptor.
Failure to provide humidification due to a
manufacturing defect. This could result in
patients developing dry airways, causing
discomfort and irritation.
The manufacturer is recalling specific batches. No other batch numbers are affected." | 11/11/2009 |
| Select | NICAS-202 | MDA(NI)2009-072 | Tec 6 Plus Desflurane vaporiser manufactured by GE Healthcare | "Tec 6 Plus Desflurane vaporiser manufactured by GE Healthcare. There is a higher than expected age related
failure of an internal component, which has
resulted in either over or under delivery of
anaesthetic agent to patients." | 09/11/2009 |
| Select | NICAS-200 | MDA(NI)2009-070 | Urine test strips. Uritest 13G manufactured by URIT Medical Electronic. | "Urine test strips. Uritest 13G manufactured by URIT Medical Electronic. Potential for misdiagnosis due to poor analytical
precision and sensitivity when testing for low levels of microalbumin and creatinine in urine. Risk of poor impregnation of the microalbumin and creatinine test pads by the sample, due to their position at the top on the strip. No instructions for use are provided by the company to aid visual interpretation of the test" | 05/11/2009 |
| Select | NICAS-201 | MDA(NI)2009-071 | Adapters used to attach LikoScale weighing systems models 200, 350and 400 to patient hoists. | "Adapters used to attach LikoScale eighing systems models 200, 350and 400 to atient hoists. Manufactured by Liko, a Hill-Rom
company. Adapters that connect the weighing scale to the hoist can fail in use, resulting in a fall and serious injury to the occupant." | 05/11/2009 |
| Select | NICAS-199 | MDA(NI)2009-069 | Home prostate screening test kits. | Home prostate screening test kits - Risk of false negative results which could lead to a missed diagnosis of prostate cancer. | 03/11/2009 |
| Select | NICAS-198 | MDA(NI)2009-068 | Careline EasiMT urine collection bag manufactured by Unomedical Ltd | "Careline EasiMT urine collection bag manufactured by Unomedical Ltd - Product code 47-60-LBH - Affected batch number 327241.
A faulty valve has been used in the manufacture of batch 327241 resulting in leaks." | 02/11/2009 |
| Select | NICAS-197 | MDA(NI)2009-067 | Aluminium double adjustable elbow crutches model RM 512700 manufactured by Trulife Limited | "Aluminium double adjustable elbow crutches model RM 512700 manufactured by Trulife Limited.
Due to a manufacturing error the handle can give way in use. This can lead to loss of stability or a fall, with the potential for serious injury." | 27/10/2009 |
| Select | NICAS-196 | MDA(NI)2009-066 | Battery chargers supplied with Aquila and Neptune bath lifts manufactured by Mountway Ltd | "Battery chargers supplied with Aquila and Neptune bath lifts manufactured by Mountway Ltd.
The surface of the battery charger can get excessively hot in use. There is potential for injury if the unit is touched, especially for those with low skin sensitivity or poor circulation." | 26/10/2009 |
| Select | NICAS-195 | MDA(NI)2009-065 | Escape 338S-SN Lite manual wheelchair manufactured by Days Healthcare Ltd | "Escape 338S-SN Lite manual wheelchair manufactured by Days Healthcare Ltd.
Contrary to information in the original instructions for use, this model of wheelchair is not suitable for use as a seat in a motor vehicle. The wheelchair could fail in a vehicle impact, leading to injury of the wheelchair occupant or others." | 22/10/2009 |
| Select | NICAS-194 | MDA(NI)2009-064 | Harrier powered wheelchairs manufactured by Invacare - Models Plus, HD and XHD. | "Harrier powered wheelchairs manufactured by Invacare - Models Plus, HD and XHD.
nvacare has revised the instructions for use for various safety aspects. Users who are unaware of these new limitations are at risk of injury." | 15/10/2009 |
| Select | NICAS-192 | MDA(NI)2009-062 | Knee replacement implant PFC Sigma manufactured by DePuy International Limited | Knee replacement implant PFC Sigma manufactured by DePuy International Limited - A manufacturing defect on the posterior chamfer region may result in fracture of the device. Specific Lots. | 14/10/2009 |
| Select | NICAS-193 | MDA(NI)2009-063 | Endotracheal tube - Portex uncuffed paediatric tracheal tubes - manufactured by Smiths Medical | "Endotracheal tube - Portex uncuffed paediatric tracheal tubes - manufactured by Smiths Medical. A manufacturing defect has resulted in some tubes having an internal diameter slightly smaller than indicated on the labelling.
The small diameter may cause a problem when suctioning a patient, and may also increase airway resistance, compromising the ability to ventilate the patient." | 14/10/2009 |
| Select | NICAS-191 | MDA(NI)2009-061 | Rea Assist wheelchairs manufactured by Invacare Rea AB. | Rea Assist wheelchairs manufactured by Invacare Rea AB - Due to an ineffective locking mechanism the backrest may suddenly detach and cause the user to fall from the wheelchair, resulting in serious injury. | 09/10/2009 |
| Select | NICAS-190 | MDA(NI)2009-060 | Dialysis bloodlines AV-SET Dialog® GB Product code 7210697 | Dialysis bloodlines AV-SET Dialog® GB Product code 7210697 Manufactured by BBraun Avitum AG.Blood leakage at the arterial chamber (PBE chamber) junction. | 22/09/2009 |
| Select | NICAS-189 | MDA(NI)2009-059 | Arjo Maxilift patient hoists manufactured by Arjo Med AB Ltd. | Arjo Maxilift patient hoists manufactured by Arjo Med AB Ltd. On certain designs of hoist, the hanger bar can detach from the jib during use due to corrosion and fatigue of the roll pin. This can cause the occupant to fall with subsequent serious injury or death. | 14/09/2009 |
| Select | NICAS-188 | MDA(NI)2009-058 | Welch Allyn vital signs monitor VSM 300 | Welch Allyn vital signs monitor VSM 300 - Failure of the audible alarm with potential for delay in recognising critical clinical signs. | 25/08/2009 |
| Select | NICAS-187 | MDA(NI)2009-057 | Smart mobile hoists manufactured by Molift Group AS. | Smart mobile hoists manufactured by Molift Group AS. Potential for the collapse of the hoist mast when in use due to incorrect assembly. This can result in serious injury or death. | 20/08/2009 |
| Select | NICAS-186 | MDA(NI)2009-056 | Servo 300 ventilator (SV300) | Servo 300 ventilator (SV300) manufactured by Siemens (now Maquet). Very high gas flow leading to bilateral pneumothoraces. | 19/08/2009 |
| Select | NICAS-185 | MDA(NI)2009-055 | Intro-Flex introducers manufactured by Edwards Lifesciences Ltd for the insertion of Swan-Ganz cathe | Intro-Flex introducers manufactured by Edwards Lifesciences Ltd for the insertion of Swan-Ganz catheters - certain batches. The blue connector on the introducer may break during use, which may result in significant blood loss. The manufacturer is recalling all affected devices. | 17/08/2009 |
| Select | NICAS-184 | MDA(NI)2009-054 | Pregnancy test for professional use. Clearview HCG manufactured by Unipath Limited. Product code 506 | "Pregnancy test for professional use. Clearview HCG manufactured by Unipath Limited. Product code 506788 (all lot numbers). Distributed from January 2008.
False positive results may be observed when the test results are interpreted beyond 3 minutes." | 11/08/2009 |
| Select | NICAS-183 | MDA(NI)2009-053 | Manual wheelchairs - Breezy 100 and Breezy 300 ranges - Manufactured by Sunrise Medical Ltd | "Manual wheelchairs - Breezy 100 and Breezy 300 ranges - Manufactured by Sunrise Medical Ltd.
These wheelchairs are not suitable for use as a seat in a motor vehicle unless they have been fitted with a transit kit. Without this kit the wheelchair could break loose in a vehicle impact, leading to injury of the wheelchair user or others." | 05/08/2009 |
| Select | NICAS-182 | MDA(NI)2009-052 | IVD INSTRUMENTATION: DS2 automated microplate processing system. Manufactured by Dynex Technologies. | "IVD INSTRUMENTATION: DS2 automated microplate processing system. Manufactured by Dynex Technologies. DS2 units with serial numbers less than 1DSA-0309 e.g 1DSA-0308, 1DSA-0307 etc.
Delay in reporting of laboratory results, which may lead to a delay in treatment or diagnosis." | 04/08/2009 |
| Select | NICAS-181 | MDA(NI)2009-051 | Thermo contour mattress for hospital beds - Manufactured by Barrington Healthcare International Ltd | Thermo contour mattress for hospital beds - Manufactured by Barrington Healthcare International Ltd - Supplied by Hill-Rom | 03/08/2009 |
| Select | NICAS-178 | MDA(NI)2009-048 | Agfa IMPAX 6.x when used in conjunction with TMVSE Voxar 3D | "Agfa IMPAX 6.x when used in conjunction with TMVSE Voxar 3D - Risk of incorrect or delayed treatment or diagnosis.
Multi-planar reformat imaging data created by Voxar 3D may be lost by Agfa IMPAX system during transfer." | 29/07/2009 |
| Select | NICAS-179 | MDA(NI)2009-049 | All University bath hoists manufactured by Unihoist Ltd | All University bath hoists manufactured by Unihoist Ltd - If the seat is used without a safety belt there is a risk that the occupant slides out of the seat and sustains a serious injury. | 29/07/2009 |
| Select | NICAS-180 | MDA(NI)2009-050 | Hospital beds - Eleganza Standard - Smart and Deluxe supplied by Pegasus or Linet | "Hospital beds - Eleganza Standard - Smart and Deluxe supplied by Pegasus or Linet.
Reminder that the emergency backrest release function on these beds may fail or become stiff and difficult to operate. This could lead to a delay in performing CPR." | 29/07/2009 |
| Select | NICAS-177 | MDA(NI)2009-047 | Stopcocks (catalogue numbers W20058 and W21372) and specific products containing non-lipid resistant | "Stopcocks (catalogue numbers W20058 and W21372) and specific products containing non-lipid resistant stopcocks, manufactured by Arrow.
Risk of leakage or air embolism due to hub cracking at the female Luer connector during delivery of infusions containing lipids." | 27/07/2009 |
| Select | NICAS-175 | MDA(NI)2009-045 | First Steps medicine feeder - Item number FS012 – various colours - Manufactured by RSW Internationa | "First Steps medicine feeder - Item number FS012 – various colours - Manufactured by RSW International Ltd.
The medicine feeder has two measurement scales, millilitres (ml) and teaspoons (tsp). Confusion between the scales has led to a serious overdose in a six month old infant who was repeatedly administered 2.5 tsp (~13ml) of medication instead of 2.5ml.
The manufacturer has recalled this product." | 20/07/2009 |
| Select | NICAS-176 | MDA(NI)2009-046 | Modular knee/hip replacement systems - MRS Cemented Stems manufactured by Stryker Orthopaedics - Spe | "Modular knee/hip replacement systems - MRS Cemented Stems manufactured by Stryker Orthopaedics - Specific lots.
Small diameter stems (8, 9 or 10 mm) may have been incorrectly implanted in the proximal femur and be at risk of fracture." | 20/07/2009 |
| Select | NICAS-174 | MDA(NI)2009-044 | Surgical gloves.Esteem® Blue with Neu-Thera™ polyisoprene surgeon undergloves | Surgical gloves. Esteem® Blue with Neu-Thera™ polyisoprene surgeon undergloves. Gloves from the affected lots can tear more easily, increasing the risk of infection. | 15/07/2009 |
| Select | NICAS-173 | MDA(NI)2009-043 | Drainage catheters manufactured by Boston Scientific | Drainage catheters manufactured by Boston Scientific On removing the catheter there is a risk that the suture keeping the pig tail shape in place, remains in the patient. | 09/07/2009 |
| Select | NICAS-172 | MDA(NI)2009-042 | Servo 300 ventilator (SV300) manufactured by Siemens (now Maquet) | Servo 300 ventilator (SV300) manufactured by Siemens (now Maquet) - The expiration valve may fail to close, leading to a risk of hypoxia if corresponding ventilator alarms are ignored. | 29/06/2009 |
| Select | NICAS-171 | MDA(NI)2009-041 | Locomotor lifting slings for adults and children manufactured by Select Healthcare (UK) Ltd. | "Locomotor lifting slings for adults and children manufactured by Select Healthcare (UK) Ltd. Potential for straps to detach in use if
safety-critical stitching is missing. This can cause the occupant to fall from the sling with the potential for serious injury or death." | 22/06/2009 |
| Select | NICAS-170 | MDA(NI)2009-040 | Device Heliosphere Bag® Intragastric Balloon manufactured by Helioscopie Medical Implants and distr | Device Heliosphere Bag® Intragastric Balloon manufactured by Helioscopie Medical Implants and distributed in the UK by UK Surgical. - Possible bowel obstruction due to full or partial early deflation of the balloon during the intended six months implantation period caused by a manufacturing welding problem. | 18/06/2009 |
| Select | NICAS-169 | MDA(NI)2009-039 | Prelude Short Sheath Introducer manufactured by Merit Medical | Prelude Short Sheath Introducer manufactured by Merit Medical - All batches of specific models affected. The sidearm tubing may detach from the sheath during use, which may result in excessive blood loss and potential blood-borne pathogen exposure to those in the surrounding area. | 16/06/2009 |
| Select | NICAS-168 | MDA-2009-038 | Implantable pacemakers - Medtronic Kappa® 600/700/900 series and Sigma® 100/200/300 series IPGs | Implantable pacemakers - Medtronic Kappa® 600/700/900 series and Sigma® 100/200/300 series IPGs. Certain Kappa® and Sigma® series pacemakers may suffer sudden unexpected failure giving rise to bradycardia symptoms (fainting or light headedness). Serious injury or death may occur in pacemaker dependent patients. | 10/06/2009 |
| Select | NICAS-167 | MDA(NI)2009-037 | Knee replacement implant. Preservation mobile bearing unicompartmental knee manufactured by DePuy In | Knee replacement implant. Preservation mobile bearing unicompartmental knee manufactured by DePuy International Limited.Revision rate higher than expected. | 04/06/2009 |
| Select | NICAS-166 | MDA(NI)2009-036 | Intravenous burette administration set manufactured by Codan | Intravenous burette administration set manufactured by Codan - The manufacturer has identified the potential for leakage from the drip chamber of certain burette sets. This could result in inadequate intravenous administration. | 02/06/2009 |
| Select | NICAS-164 | MDA(NI)2009-034 | Suction catheters. OP-Flex Poole (handle and set) manufactured by Unomedical Limited. | Suction catheters. OP-Flex Poole (handle and set) manufactured by Unomedical Limited. Risk of the suction catheter’s outer Poole cover detaching from the handle and remaining in the patient due to a manufacturing fault. | 01/06/2009 |
| Select | NICAS-165 | MDA(NI)2009-035 | Infusion pumps - Colleague single and triple-channel volumetric infusion pumps manufactured by Baxte | "Infusion pumps - Colleague single and triple-channel volumetric infusion pumps manufactured by Baxter.
Risk of interruption of infusions due to:
1. software faults resulting in the pump stopping and alarming. It may not be possible to restart an affected pump.
2. increased occurrence of ‘damaged battery’ messages.
3. damage from improper cleaning." | 01/06/2009 |
| Select | NICAS-163 | MDA(NI)2009-033 | Posture hip belts for use on paediatric seating systems and buggies - Manufactured and supplied by R | The belt has been manufactured from material that is too thin and this could slip through the buckles when the belt is in use. Consequently the occupant could slide down in the seat and suffer positional asphyxiation. | 11/05/2009 |
| Select | NICAS-161 | MDA(NI)2009-031 | Paediatric Tracheostomy Tubes Shiley 3.0 PED Manufactured by Tyco HealthCare | Paediatric Tracheostomy Tubes Shiley 3.0 PED Manufactured by Tyco HealthCare (now Corvidien) Lot No 0806000858 and 0807002502. | 28/04/2009 |
| Select | NICAS-160 | MDA(NI)2009-030 | Disposable endoscopic polypectomy snares manufactured by ConMed - Specific product and lot codes. | Disposable endoscopic polypectomy snares manufactured by ConMed - Specific product and lot codes. There is a risk that the snare loop may detach and fall into the patient’s stomach or alimentary canal, requiring an additional procedure to remove it. | 27/04/2009 |
| Select | NICAS-157 | MDA-2009-028 | Goldmann applanation tonometer prism - Manufactured by Haag-Streit Ag. | Goldmann applanation tonometer prism - Manufactured by Haag-Streit Ag. Damage to the tonometer prism due to the use of inappropriate disinfectants may result in corneal irritation. | 21/04/2009 |
| Select | NICAS-158 | MDA(NI)2009-029 | Automatic external defibrillator: Welch Allyn AED 10 (previously branded as MRL JumpStart) | Automatic external defibrillator: Welch Allyn AED 10 (previously branded as MRL JumpStart) Specific serial numbers are affected. Used in hospitals, ambulances and public places. Device recall due to quality and performance problems. Devices can fail suddenly and prevent defibrillation of a patient. | 21/04/2009 |
| Select | NICAS-156 | MDA(NI)2009-027 | Ambulatory insulin infusion pump. Only serial numbers up to and | "Due to a design fault, the ‘up’ and ‘down’ arrow buttons can fail. If both the buttons fail at the same time, the activation of the bolus function and the adjustment of the preset basal function will be inhibited.
This means that there is a risk that insulin therapy is compromised." | 20/04/2009 |
| Select | NICAS-154 | MDA(NI)2009-026 | GE Healthcare Anaesthetic CareStations - Affected models Aisys and Avance - Serial number ranges Ais | "GE Healthcare Anaesthetic CareStations - Affected models Aisys and Avance - Serial number ranges Aisys: ANAH00100-ANAM00498 - Avance: ANBG00100-ANBM00530
An intermittent electrical connection with the On/standby switch can cause the machine to shutdown unexpectedly. The machine alarms and then a message appears on screen stating ‘System Shutdown in 8 seconds’." | 15/04/2009 |
| Select | NICAS-153 | MDA(NI)2009-025 | Mikrozid® sensitive wipes (alcohol free surface disinfection wipes for medical devices) manufactured | Mikrozid® sensitive wipes (alcohol free surface disinfection wipes for medical devices) manufactured by Schulke & Mayr - Tub (product code 109184) and refill pouches (product code 109190). The disinfecting property of the Mikrozid sensitive wipe cannot be guaranteed. | 09/04/2009 |
| Select | NICAS-152 | MDA(NI)2009-024 | Ambulatory insulin infusion pump. Accu-Chek Spirit manufactured by Roche Diagnostics. | "Ambulatory insulin infusion pump. Accu-Chek Spirit manufactured by Roche Diagnostics. Only serial numbers up to and including 10006093 are affected (number is located on the back of the pump). Due to a design fault, the ‘up’ and ‘down’ arrow buttons can fail. If both the buttons fail at the same time, the activation of the bolus function and the adjustment of the preset basal function will be inhibited.
This means that there is a risk that insulin therapy is compromised." | 07/04/2009 |
| Select | NICAS-151 | MDA-2009-023 | Zenith® abdominal aortic aneurysm (AAA) endovascular grafts and associated H&L-B One-ShotTM Introduc | Zenith® abdominal aortic aneurysm (AAA) endovascular grafts and associated H&L-B One-ShotTM Introduction Systems. Manufactured by Cook Medical Incorporated. Potential for serious injury or death of the patient due to difficulty releasing or inability to release the suprarenal stent during graft deployment. | 02/04/2009 |
| Select | NICAS-150 | MDA(NI)2009-022 | Posture belt manufactured byJames Leckey Designs Ltd for use on their paediatric seating systems: Mo | Posture belt manufactured byJames Leckey Designs Ltd for use on their paediatric seating systems: Mobile Advance Seat Contoured Advance Seat Squiggles Early Sitting System Squiggles Saddle Seat - The central plastic buckle degrades and can fail in use. This may result in the occupant falling from the seat and injuring themselves. | 01/04/2009 |
| Select | NICAS-149 | MDA(NI)2009-021 | Insulin pen needles: Labelled as Novo Nordisk Ltd Novofine® Needles 31G, 0.25 mm x 6 mm lot number 0 | Insulin pen needles: Labelled as Novo Nordisk Ltd Novofine® Needles 31G, 0.25 mm x 6 mm lot number 08J02S. Counterfeit Novofine needles have been placed on the UK market. | 27/03/2009 |
| Select | NICAS-147 | MDA(NI)2009-020 | All Servo ventilators 300 and 300A with automode function. Manufactured by Maquet Critical Care AB ( | All Servo ventilators 300 and 300A with automode function. Manufactured by Maquet Critical Care AB (previously Siemens) - Risk of inadequate ventilation of neonatal or paediatric patients without warning by any alarm. | 25/03/2009 |
| Select | NICAS-146 | MDA(NI)2009-019 | Insulin pen injection devices: Owen Mumford Autopen® Classic (1 unit 3ml), 1-21 units. Product code: | "Insulin pen injection devices: Owen Mumford Autopen® Classic (1 unit 3ml), 1-21 units. Product code: AN3810 Affected lots: CJF, DBR, DEX, DMP, DND BRG and CCW.
Affected devices may fail to dispense insulin. Underdosing of insulin may lead to hyperglycaemia, which could lead to long term deterioration in health." | 18/03/2009 |
| Select | NICAS-145 | MDA(NI)2009-018 | All Quickie Groove battery powered wheelchairs manufactured by Sunrise Medical. This Alert supersede | "All Quickie Groove battery powered wheelchairs manufactured by Sunrise Medical - Groove wheelchairs have not been fitted with a heavy duty transit kit or a restraining strap for the powered elevating leg rest. This strap allows the wheelchair to be used as a seat in a motor vehicle. In the event of a vehicle impact the wheelchair or leg rest could break loose, leading to injury to the wheelchair user or others.
This Alert supersedes and replaces MDEA(NI)2008/076." | 09/03/2009 |
| Select | NICAS-144 | MDA(NI)2009-017 | Staining solution for ophthalmic surgery - MembraneBlue© 0.5ml syringe manufactured | Staining solution for ophthalmic surgery - MembraneBlue© 0.5ml syringe manufactured - The plunger may stick within the barrel of the syringe. This has led to the use of excessive force during injection of the solution, resulting in a sudden jet of liquid that can cause serious damage to intraocular tissues. | 04/03/2009 |
| Select | NICAS-142 | MDA(NI)2009-015 | All Action 2000 manual wheelchairs manufactured by Invacare with serial numbers from 7007533957 to 7 | All Action 2000 manual wheelchairs manufactured by Invacare with serial numbers from 7007533957 to 7008568013 inclusive - The bolts used to secure the castor assemblies to the wheelchair frame can fail in use. This has caused occupants to fall from their wheelchair and sustain injuries. | 24/02/2009 |
| Select | NICAS-143 | MDA(NI)2009-016 | Total knee replacement implant femoral components – PFC SIGMA. Manufactured by DePuy International L | Total knee replacement implant femoral components – PFC SIGMA. Manufactured by DePuy International Limited - Potential for implanting incorrect anatomical components due to unclear labelling. | 24/02/2009 |
| Select | NICAS-141 | MDA-2009-014 | UNISTAT L floor stand for diagnostic X-ray and superficial X-ray therapy systems - Manufactured by M | "UNISTAT L floor stand for diagnostic X-ray and superficial X-ray therapy systems - Manufactured by MECALL Srl - The MHRA has received a report of the X-ray tube head falling onto the table after the support cable and the backup ‘safety device’ failed simultaneously.
The tube head weighs 40 kg and there is a risk of death or serious patient injury if this failure occurs during examination." | 23/02/2009 |
| Select | NICAS-139 | MDA(NI)2009-012 | Aquarius haemofiltration machine - Manufactured by Edwards Lifesciences Ltd | "Aquarius haemofiltration machine - Manufactured by Edwards Lifesciences Ltd - Software versions 4.01.11, 4.01.12 and 6.01. - This alert deals with two separate issues:
Issue 1: The instructions in the operating manual describing the tubing set up and haemoperfusion filter choice are incorrect.
Issue 2: It is possible to override fluid balance alarms. This can result in excess fluid remaining, or being removed, during therapy." | 18/02/2009 |
| Select | NICAS-140 | MDA(NI)2009-013 | Unomedical Unilect 4831Q and 4841P short term adult and paediatric ECG monitoring electrodes | "Unomedical Unilect 4831Q and 4841P short term adult and paediatric ECG monitoring electrodes - Degradation in performance after defibrillation.
Following defibrillation the observed ECG waveform may show a 'flatline' (asystole). This may result in inappropriate treatment that could be detrimental to the patient." | 18/02/2009 |
| Select | NICAS-137 | MDA(NI)2009-010 | All models of Jazzy, Quantum and LX battery powered wheelchairs manufactured by Pride Mobility Ltd. | All models of Jazzy, Quantum and LX battery powered wheelchairs manufactured by Pride Mobility Ltd - On some models of Jazzy, Quantum and LX powered wheelchairs the manufacturer has fitted tie down securement brackets (known as the Transit Securement Package – TSP) before delivery and has now issued updated instructions for use. | 16/02/2009 |
| Select | NICAS-138 | MDA(NI)2009-011 | Bacteriology culture medium. Chocolate agar + PolyViteX VCAT3 agar. Manufactured by BioMerieux Ltd. | Bacteriology culture medium. Chocolate agar + PolyViteX VCAT3 agar. Manufactured by BioMerieux Ltd. - Risk of false negative results for Neisseria gonorrhoeae (N.gonorrhoeae), which may lead to misdiagnosis and potential missed treatment. | 16/02/2009 |
| Select | NICAS-136 | MDA(NI)2009-009 | Blood collection tubes: Becton Dickinson (BD) Diagnostics Vacutainer® Serum tubes (16 x 100mm) red. | "Blood collection tubes: Becton Dickinson (BD) Diagnostics Vacutainer® Serum tubes (16 x 100mm) red. - Affected lots: 8015159, 8029093, 8059728, 8095550, 8113634 and 8161235.
When the above listed tubes are used with the BD reusable holder, or non-BD needle holders, there is the potential for the HemogardTM cap to come off, which may cause spillage and exposure to blood from open tubes." | 12/02/2009 |
| Select | NICAS-135 | MDA(NI)2009-008 | Ligating clips distributed by Teleflex Medical. | "Ligating clips distributed by Teleflex Medical.
Weck brand including Hem-o-lok, Horizon, Hemoclip Traditional and Hemoclip Plus. - Holes have been detected in the tray of certain sterile packaged units, which may compromise the sterility of the product." | 05/02/2009 |
| Select | NICAS-134 | MDA(NI)2009-007 | EasiCath intermittent urinary catheters manufactured by Coloplast – recall of various models and bat | EasiCath intermittent urinary catheters manufactured by Coloplast – recall of various models and batches - Some catheters have been caught in the welding of the packaging which has caused the catheter tip to be cut off or partly cut off, leaving a sharp edge. This would pose a risk of urethral injury if the user did not detect the sharp edges and tried to insert the catheter. | 04/02/2009 |
| Select | NICAS-133 | MDA(NI)2009-006 | Days Healthcare Ltd aluminium walking frames. All models with batch number E08/30. | Days Healthcare Ltd aluminium walking frames. All models with batch number E08/30. - The adjustment spring clips in this batch of walking frames are faulty and can fracture. This has resulted in the frame legs collapsing, with the subsequent fall of the user. | 29/01/2009 |
| Select | NICAS-132 | MDA(NI)2009-005 | Colleague triple-channel mono volumetric infusion pumps with software version 5.09.92 and CXE pumps | Colleague triple-channel mono volumetric infusion pumps with software version 5.09.92 and CXE pumps with software version 6.13.92. - Unfamiliarity with the new method of programming the piggyback mode may lead to delays in treatment. | 28/01/2009 |
| Select | NICAS-131 | MDA(NI)2009-004 | Enteral feeding pump. Flocare Infinity pump model 35679 and Flocare Infinity pump model 35679 | Enteral feeding pump. Flocare Infinity pump model 35679 and Flocare Infinity pump model 35679 - Due to a software irregularity, pumps have the potential to deliver feed at a higher rate than that programmed. | 22/01/2009 |
| Select | NICAS-130 | MDA(NI)2009-003 | Sae-Flo Md Extension Set With Y-Connector (Lot Number 80623/1 Only) | Sae-Flo Md Extension Set With Y-Connector (Lot Number 80623/1 Only) - Manufacturer: Wescott Medical Ltd. Product Code: WEPCA200AY. | 19/01/2009 |
| Select | NICAS-129 | MDA(NI)2009-002 | All Folysil X-TRA indwelling urinary catheters manufactured by Coloplast, Mentor Medical or Porges | Recall - All Folysil X-TRA indwelling urinary catheters manufactured by Coloplast, Mentor Medical or Porges - The fluid in the prefilled syringe packed with the catheter has not been sterilized. | 16/01/2009 |
| Select | NICAS-128 | MDA(NI)2009-001 | Need to report medical device adverse incidents | "Please Note the NEW format for NIAIC Medical Devices Alerts (MDA’s)
Medical device alerts in Northern Ireland are based on the format and content of the Medicines and Healthcare products Regulatory Agency’s (MHRA) Alerts" | 07/01/2009 |
| Select | NICAS-127 | MDEA(NI)2008-092 | Oxford disposable slings supplied by Joerns Healthcare. | Oxford disposable slings supplied by Joerns Healthcare - The sling material can tear resulting in the occupant falling out of the sling. | 22/12/2008 |
| Select | NICAS-125 | MDEA(NI)2008-090 | Anaesthesia kits and epidural filters manufactured by Becton Dickinson (BD). Specific models and lot | Anaesthesia kits and epidural filters manufactured by Becton Dickinson (BD) - Specific models and lot numbers - Risk of infection as the sterile barrier of the unit pack may be compromised due to holes in the packaging. | 17/12/2008 |
| Select | NICAS-124 | MDEA(NI)2008-089 | IVD point of care test – prostate specific antigen (PSA) manufactured by Innovacon Inc USA, Surescre | IVD point of care test – prostate specific antigen (PSA) manufactured by Innovacon Inc USA, Surescreen and Fortress Diagnostics - Potential for false negative results due to reduced stability. | 12/12/2008 |
| Select | NICAS-123 | MDEA(NI)2008-088 | PVB arterial pressure monitoring kit. | PVB arterial pressure monitoring kit - Due to a manufacturing error, there may be loose tap inserts in these kits. This may result in the stopcock becoming dislodged, leading to arterial bleeding. | 09/12/2008 |
| Select | NICAS-121 | MDEA(NI)2008-087 | Adult and paediatric manual resuscitators, manufactured by Marshall Products Ltd | Adult and paediatric manual resuscitators, manufactured by Marshall Products Ltd - There may be significant difficulty in connecting or disconnecting the device’s 15mm outlet directly onto airway devices such as endotracheal tubes or laryngeal masks. | 21/11/2008 |
| Select | NICAS-122 | MDEA(NI)2008-086 | Tower Fans, Micromark | Tower Fans, Micromark - Risk of fire. | 21/11/2008 |
| Select | NICAS-120 | MDEA(NI)2008-085 | LIFEPAK CR Plus automatic external defibrillator manufactured by Medtronic Physio-Control | LIFEPAK CR Plus automatic external defibrillator manufactured by Medtronic Physio-Control - Failure to deliver therapy. A faulty internal cable in defibrillators manufactured between November 2006 and March 2008 means the defibrillator may fail to power on. | 19/11/2008 |
| Select | NICAS-119 | MDEA(NI)2008-084 | Frazier and Poole suction instruments used in surgery. | Frazier and Poole suction instruments used in surgery - Manufactured by ConMed Corporation. Risk of compromised sterility due to unvalidated method of packaging inspection. | 17/11/2008 |
| Select | NICAS-118 | MDEA(NI)2008-083 | Enteral feeding pump. ClearStar model M771 manufactured by Abbott Nutrition. Specific serial numbers | Enteral feeding pump. ClearStar model M771 manufactured by Abbott Nutrition. Specific serial numbers - Risk of under-infusion due to cracking/breaking of an internal adapter bracket. | 12/11/2008 |
| Select | NICAS-117 | MDEA(NI)2008-082 | Mermaid, Dipper and Ranger bath hoists manufactured by Joerns Healthcare (part of Sunrise Medical Lt | Mermaid, Dipper and Ranger bath hoists manufactured by Joerns Healthcare (part of Sunrise Medical Ltd) - Risk of a fall from the hoist resulting in serious injury or death due to lack of safety belt. | 10/11/2008 |
| Select | NICAS-116 | MDEA(NI)2008-081 | Breezy Moonlite manual wheelchair manufactured by Sunrise Medical | Breezy Moonlite manual wheelchair manufactured by Sunrise Medical - Sudden failure of the backrest hinge can lead to injury of the occupant and/or carer. | 29/10/2008 |
| Select | NICAS-115 | MDEA(NI)2008-080 | Storm3, Storm TT, Typhoon and Typhoon II battery powered wheelchairs manufactured by Invacare. | Storm3, Storm TT, Typhoon and Typhoon II battery powered wheelchairs manufactured by Invacare - The original tie-down brackets fitted to these wheelchairs are not suitable for the new heavy duty four point webbing tie-down systems manufactured by Unwin Safety Systems Limited. | 28/10/2008 |
| Select | NICAS-113 | MDEA(NI)2008-078 | Savanah 2” and 4” raised toilet seats manufactured by Homecraft Rolyan. | "Savanah 2” and 4” raised toilet seats manufactured by Homecraft Rolyan.The rubber pad on the mounting brackets can become detached. This means the seat cannot be tightened securely to the toilet and may slip when used causing the user to fall
and injure themselves." | 23/10/2008 |
| Select | NICAS-114 | MDEA(NI)2008-079 | Kid Active folding manual wheelchair with swing away footrests manufactured by Lomax Mobility Ltd. | Kid Active folding manual wheelchair with swing away footrests manufactured by Lomax Mobility Ltd. Risk of fall and serious injury due to limited forward stability. | 23/10/2008 |
| Select | NICAS-111 | MDEA(NI)2008-077 | Solus laryngeal mask airway manufactured by Intersurgical | Solus laryngeal mask airway manufactured by Intersurgical - Possibility of moulding defects in the device’s 15mm connector, which could cause it to break off during use. | 08/10/2008 |
| Select | NICAS-110 | MDEA(NI)2008-076 | Quickie Groove battery powered wheelchair manufactured by Sunrise Medical. | Quickie Groove battery powered wheelchair manufactured by Sunrise Medical - Inadequate instructions when using the wheelchair as a seat in a vehicle. | 07/10/2008 |
| Select | NICAS-107 | MDEA(NI)2008-074 | Access and Accent attendant propelled wheelchairs manufactured by Remploy Healthcare. | Access and Accent attendant propelled wheelchairs manufactured by Remploy Healthcare - Rear tie-down location brackets not fitted. | 07/10/2008 |
| Select | NICAS-108 | MDEA(NI)2008-075 | Alternating air mattress pumps models PHP198,396, 398 and 399 supplied by Park House Healthcare Ltd. | Alternating air mattress pumps models PHP198,396, 398 and 399 supplied by Park House Healthcare Ltd - Failure of timer mechanisms leading to the loss of pressure relief. | 07/10/2008 |
| Select | NICAS-106 | MDEA(NI)2008-073 | The risk to water supplies, in sensitive hospital areas, from microbiological water treatment. | The risk to water supplies, in sensitive hospital areas, from microbiological water treatment - Failure to remove chemicals, (Silver-stabilised hydrogen peroxide and similar based chemicals), used for microbiological treatment of water supplies can produce a risk of exposure to potentially dangerous chemicals, which can cause severe injury to patients. | 06/10/2008 |
| Select | NICAS-105 | MDEA(NI)2008-072 | Histology slide staining automated processors: Benchmark and Discovery manufactured by Ventana Medic | "Histology slide staining automated processors:
Benchmark and Discovery manufactured by Ventana Medical Systems Inc. - Risk of incorrect staining results, which may lead to misdiagnosis." | 26/09/2008 |
| Select | NICAS-102 | MDA-2008-065 | Implantable cardioverter defibrillators – all manufacturers and models. (Formly MDEA(NI)2008-71) | "Implantable cardioverter defibrillators – all manufacturers and models. Risk of electric shock to clinicians or mortuary personnel while removing implantable cardioverter defibrillators (ICDs);
Risk of explosion during ICD incineration; Need to maintain device/data integrity for ICDs subject to investigation." | 23/09/2008 |
| Select | NICAS-101 | MDEA(NI)2008-070 | Instrumentation for total knee replacement surgery: NexGen Articular Surface Insertion Instrument ma | Instrumentation for total knee replacement surgery: NexGen Articular Surface Insertion Instrument manufactured by Zimmer Inc - Recall of instruments that do not meet material specifications. | 22/09/2008 |
| Select | NICAS-100 | MDEA(NI)2008-069 | Total knee replacement implants: Stryker Orthopaedics Kinemax Plus Revision TS Tibial Inserts (speci | Total knee replacement implants: Stryker Orthopaedics Kinemax Plus Revision TS Tibial Inserts. Risk of loosening, excessive wear and fracture of knee replacement components, due to a manufacturing defect. | 19/09/2008 |
| Select | NICAS-99 | MDEA(NI)2008-068 | Neurostimulator programmers manufactured by Medtronic – N’Vision® and InterStim iCon® used with Inte | Neurostimulator programmers manufactured by Medtronic – N’Vision® and InterStim iCon® used with InterStim implantable neurostimulator model 3023 for pelvic floor disorders. - An error in the programmer software (revision NNB_01) may lead to false warnings of a low battery status. There is a risk that pre-existing symptoms may return if the device ceases to function when true low or end of service battery warnings are subsequently ignored. | 11/09/2008 |
| Select | NICAS-96 | MDEA(NI)2008-066 | The Supply of Syringe and Needles | The Supply of Syringe and Needles - During September 2008 the regional contract for the supply of syringes and needles to HSC will change across Northern Ireland. All syringes and needles supplied under the regional contract will be supplied by Becton Dickinson (BD) Medical. This change will require all syringe pumps used throughout the HSC system to be calibrated in accordance with the manufacturers instructions for use for the syringe type being used. | 04/09/2008 |
| Select | NICAS-97 | MDEA(NI)2008-067 | Obturator – Venflon™ IV cannula obturator manufactured by BD. Product code numbers 394252 and 394253 | Obturator – Venflon™ IV cannula obturator manufactured by BD. Product code numbers 394252 and 394253. Various lot numbers. - Due to a manufacturing problem, there may be cracks and holes in the packaging of the listed obturators for Venflon™ cannulae, which could compromise sterility. | 04/09/2008 |
| Select | NICAS-95 | MDEA(NI)2008-065 | Sonesta 6210 fluoroscopy procedure table manufactured by Stille. | Sonesta 6210 fluoroscopy procedure table manufactured by Stille - The MHRA has received a report of uncontrolled movement of this device caused by a short circuit in the handset. The device has a battery backup and movement cannot be stopped by disconnecting the device from the mains. There is a risk of serious patient injury if this failure occurs during examination with the c arm. | 13/08/2008 |
| Select | NICAS-94 | MDEA(NI)2008-064 | Emergency and transport EMS ventilator circuits, product code W196-002, lot number 20070709, manufac | Emergency and transport EMS ventilator circuits, product code W196-002, lot number 20070709, manufactured by Galemed Corporation and supplied by Smiths Medical. Extension of recall – valve in the breathing system will not open, resulting in a lack of oxygen delivery. | 05/08/2008 |
| Select | NICAS-92 | MDEA(NI)2008-062 | Carendo multi-purpose hygiene chair manufactured by Arjo. | Carendo multi-purpose hygiene chair manufactured by Arjo - Risk of entrapment of genitalia. | 04/08/2008 |
| Select | NICAS-93 | MDEA(NI)2008-063 | Laboratory analyser – ADVIA Centaur CP immunoassay system, serial number 086-A001-XX, manufactured b | Laboratory analyser – ADVIA Centaur CP immunoassay system, serial number 086-A001-XX, manufactured by Siemens Healthcare Diagnostics - Dispensing errors using the 10?l probe may have lead to falsely low results for alpha-fetoprotein (AFP) and myoglobin tests. | 04/08/2008 |
| Select | NICAS-91 | MDEA(NI)2008-061 | Blood glucose meters – Ascensia Contour (5-second) manufactured by Bayer Diabetes Care. | Blood glucose meters – Ascensia Contour (5-second) manufactured by Bayer Diabetes Care - Affected devices may show falsely high readings when testing samples from neonates less than 24 hours old. This may mask hypoglycaemia. | 31/07/2008 |
| Select | NICAS-90 | MDEA(NI)2008-060 | Medi-Tec Classic hoist manufactured by Aidservice Ltd | Medi-Tec Classic hoist manufactured by Aidservice Ltd - Risk of spreader bar becoming detached in use and dropping the hoist occupant. | 30/07/2008 |
| Select | NICAS-89 | MDEA(NI)2008-059 | Laboratory analysers and their associated assays – ADVIA Centaur and ADVIA Centaur XP Immunoassay Sy | Laboratory analysers and their associated assays – ADVIA Centaur and ADVIA Centaur XP Immunoassay Systems. | 25/07/2008 |
| Select | NICAS-88 | MDEA(NI)2008-058 | Smiths Medical Portex™ Blue Line Ultra tracheostomy kits, | "Smiths Medical Portex™ Blue Line Ultra tracheostomy kits, lot no. 499265 -Blue Line Ultra Suctionaid tracheostomy change kits (product code 100/880/080) from lot 499265 will contain a Blue Line Ultra fenestrated, uncuffed tube. Although this tube will maintain an airway if used, it will reduce ventilation efficiency and will not provide any direct suctioning ability.
Smiths Medical is recalling these devices due to the incorrect labelling" | 23/07/2008 |
| Select | NICAS-87 | MDEA(NI)2008-057 | Unomedical OP suction tubing lot 182281 only. | Unomedical OP suction tubing lot 182281 only. Product code 16172182. - Due to a manufacturing error there is the potential for the tubing to collapse whilst in use, preventing suction | 22/07/2008 |
| Select | NICAS-85 | MDEA(NI)2008-055 | Kimal safety fistula needle (all product codes and lots). | Kimal safety fistula needle (all product codes and lots) - Kimal is aware of the potential for the unintentional retraction of the cannula into the protection sheath, which can result in exsanguination. As a result, Kimal is recalling all lots of the device. | 21/07/2008 |
| Select | NICAS-86 | MDEA(NI)2008-056 | Puma and Beatle battery powered wheelchairs manufactured by Movingpeople.net or Handicare. | Puma and Beatle battery powered wheelchairs manufactured by Movingpeople.net or Handicare - Some variants of the Puma and Beatle are too heavy for standard four point webbing tie-down systems for use in a vehicle. | 21/07/2008 |
| Select | NICAS-84 | MDEA(NI)2008-054 | Harrier Heavy Duty (HD) battery powered wheelchair manufactured by Invacare | "Harrier Heavy Duty (HD) battery powered wheelchair manufactured by Invacare - These wheelchairs have been supplied without battery transportation straps. This means there is the potential for the battery to detach from the frame in the event of a vehicle impact.
Additionally, changes have also been made to the instructions for use with regard to the wheelchairs use as a seat in a vehicle." | 08/07/2008 |
| Select | NICAS-83 | MDEA(NI)2008-053 | Smiths Medical Graseby Omnifuse and Omnifuse PCA syringe pumps | "Smiths Medical Graseby Omnifuse and Omnifuse PCA syringe pumps - Possibility of patients being given an additional/unnecessary infusion when syringes are changed or infusions restarted when using DrugPro software.
If the user selects – but does not confirm – a drug protocol from the drug protocol library and then resets/stops the pump, the previously infused volume will not be added to the ‘total volume infused’ display." | 04/07/2008 |
| Select | NICAS-81 | MDEA(NI)2008-051 | Procedure packs from various manufacturers which contain BD Medical Surgical Systems 2ml, 5ml and 10 | Procedure packs from various manufacturers which contain BD Medical Surgical Systems 2ml, 5ml and 10ml Plastipak Luer slip syringes. Potential for the BD Luer slip syringes supplied in procedure packs to spontaneously disconnect or fail to maintain a secure connection to Luer fittings of other devices. | 03/07/2008 |
| Select | NICAS-82 | MDEA(NI)2008-052 | BabyCare crib trolleys with drop-shelves, manufactured by Huntleigh Healthcare and Hoskins Medical E | BabyCare crib trolleys with drop-shelves, manufactured by Huntleigh Healthcare and Hoskins Medical Equipment. The drop-shelves fitted to these crib trolleys may collapse under the weight of a baby bath and should not be used for this purpose. This is stated in the instructions for use, and devices manufactured since May 2005 have also had a warning label put on the shelf. | 03/07/2008 |
| Select | NICAS-79 | MDEA(NI)2008-049 | Gambro and Hospal blood sets (lot numbers 0806 – 0817) | "Gambro and Hospal blood sets (lot numbers 0806 – 0817) - Gambro has identified the potential for a total or partial occlusion of the arterial (red) and/or
venous (blue) dialyser connectors of these blood tubing sets. This is due to a moulding defect." | 01/07/2008 |
| Select | NICAS-78 | MDEA(NI)2008-048 | Action³ manual wheelchair with fixed back and height adjustable push handles manufactured by Invacar | Action³ manual wheelchair with fixed back and height adjustable push handles manufactured by Invacare - Fixed backrests on Action³ wheelchairs fitted with height adjustable push handles have fractured in use, placing the occupant and carer at risk of injury. | 26/06/2008 |
| Select | NICAS-77 | MDEA(NI)2008-047 | Pregnancy test kits– Clinitest hCG Cassette, lot numbers 97552 and 97574 (professional use only), ma | Pregnancy test kits– Clinitest hCG Cassette, lot numbers 97552 and 97574 (professional use only), manufactured by Siemens Healthcare Diagnostics - Recall due to the potential for false negative results. | 25/06/2008 |
| Select | NICAS-76 | MDEA(NI)2008-046 | FocalSim radiotherapy treatment planning software manufactured by Computerized Medical Systems Inc. | FocalSim radiotherapy treatment planning software manufactured by Computerized Medical Systems Inc. - Potential for miscalculation and incorrect display of patient doses leading to over-exposure and/or unnecessary exposure(s) to radiation. | 18/06/2008 |
| Select | NICAS-73 | MDEA(NI)2008-043 | Medtronic Physio-Control LIFEPAK® 12, LIFEPAK® 20 and LIFEPAK® 20e external defibrillators with cert | Medtronic Physio-Control LIFEPAK® 12, LIFEPAK® 20 and LIFEPAK® 20e external defibrillators with certain settings - When used in AED mode with ‘Auto Analyze’ ON, the ECG analysis (Shock Advisory System™) may start before a warning is given to the user to stand clear of the patient. This can result in inappropriate shock or no shock recommendations being made by the device due to CPR or movement artefacts. | 17/06/2008 |
| Select | NICAS-74 | MDEA(NI)2008-044 | Electrosurgical single-use, sterile blades and needles - ‘Universal’ and ‘Ultraclean’ electrodes man | Electrosurgical single-use, sterile blades and needles - ‘Universal’ and ‘Ultraclean’ electrodes manufactured by ConMed. A limited number of electrosurgical blades and needles may have an inadequate packaging seal, potentially compromising the sterility of the device (see appendix for list of relevant catalogue and lot numbers). | 17/06/2008 |
| Select | NICAS-75 | MDEA(NI)2008-045 | Chest drain: Thoraseal II chest drainage unit manufactured by Covidien | Chest drain: Thoraseal II chest drainage unit manufactured by Covidien - Inadvertent disconnection of the drainage tubing from the bottle. | 17/06/2008 |
| Select | NICAS-72 | MDEA(NI)2008-042 | Implantable drug pumps for intrathecal therapy. All manufacturers. | Implantable drug pumps for intrathecal therapy. All manufacturers. Risk of temporary or permanent neurological impairment due to inflammatory or granulomatous mass formation at the catheter tip. | 09/06/2008 |
| Select | NICAS-69 | MDEA(NI)2008-040 | Invasive blood pressure monitoring sets: LogiCal, NovaTrans and TranStar models with trigger flush d | Invasive blood pressure monitoring sets: LogiCal, NovaTrans and TranStar models with trigger flush device. Manufactured by Smiths Medical from October 2007 to February 2008 inclusive. A fault in the manufacture of the trigger flush device can lead to over-infusion of fluid and falsely elevated blood pressure measurements. | 04/06/2008 |
| Select | NICAS-66 | MDEA(NI)2008-038 | Battery powered wheelchairs, Storm and Storm True Track (TT) | Battery powered wheelchairs, Storm and Storm True Track (TT) Manufactured by Invacare - The Storm TT wheelchair and some variants of the Storm are too heavy for any standard four point webbing tie-down system commercially available for use in a vehicle. | 28/05/2008 |
| Select | NICAS-64 | MDEA(NI)2008-036 | Patient weigh scales | Patient weigh scales - Potential for medication errors due to incorrectly calibrated or type of weigh scales. | 23/05/2008 |
| Select | NICAS-63 | MDEA(NI)2008-035 | Fluid warming sets. Level 1® normothermic IV fluid administration and irrigation sets - D/DI and IR/ | Fluid warming sets. Level 1® normothermic IV fluid administration and irrigation sets - D/DI and IR/IRI series manufactured by Smiths Medical - Some sets have small holes in the inner lumen (aluminium tube) that allow contamination of the infusate with the heating fluid. | 22/05/2008 |
| Select | NICAS-62 | MDEA(NI)2008-034 | Masimo Rainbow Rad-57 Pulse CO-Oximeter | Masimo Rainbow Rad-57 Pulse CO-Oximeter - Elevated levels of methaemoglobin (MetHb) will lead to inaccurate carboxyhaemoglobin (COHb) readings (SpCO) and or Elevated levels of either MetHb or COHb will lead to inaccurate oxygen saturation readings (SpO2). | 20/05/2008 |
| Select | NICAS-61 | MDEA(NI)2008-033 | Robertshaw endobronchial tubes (PVC, disposable) all sizes – manufactured by Phoenix Medical, a P3 M | Robertshaw endobronchial tubes (PVC, disposable) all sizes – manufactured by Phoenix Medical, a P3 Medical Ltd company.There is a risk of plastic debris from the intubation stylet entering the patient’s airway due to a manufacturing defect. | 14/05/2008 |
| Select | NICAS-59 | MDEA(NI)2008-032 | Walking frames for adults and children manufactured by Trulife Limited. | Walking frames for adults and children manufactured by Trulife Limited - The plastic height adjustment clips can fail, causing the user to fall. | 30/04/2008 |
| Select | NICAS-58 | MDEA(NI)2008-031 | Surgical blades manufactured by ConMed Linvatec Hall | Surgical blades manufactured by ConMed Linvatec Hall - Possibility of holes in the packaging which may compromise sterility | 30/04/2008 |
| Select | NICAS-57 | MDEA(NI)2008-030 | Beatle and Puma battery powered wheelchairs manufactured by Movingpeople.net or Handicare. | Beatle and Puma battery powered wheelchairs manufactured by Movingpeople.net or Handicare - wheelchairs in front wheel drive (FWD) configuration have tipped when travelling on slopes. | 21/04/2008 |
| Select | NICAS-56 | MDEA(NI)2008-029 | Disposable pen torch manufactured by Merlin Medical Limited and distributed by Williams Medical Supp | Disposable pen torch manufactured by Merlin Medical Limited and distributed by Williams Medical Supplies - Model No W2137 - Incorrect bulb placement due to a manufacturing fault which can cause the bulb to explode upon illumination or be damaged during normal use. | 21/04/2008 |
| Select | NICAS-55 | MDEA(NI)2008-028 | Well-Shin WS-023 power lead adapters originally supplied by Pegasus Ltd | Well-Shin WS-023 power lead adapters originally supplied by Pegasus Ltd with Eleganza and Praktika hospital beds and Homecare and Vitalia community beds - Risk of electrocution to patients, bed occupants, staff and others. | 17/04/2008 |
| Select | NICAS-54 | MDEA(NI)2008-027 | Birthright birthing bed mattresses manufactured by Huntleigh Healthcare | Birthright birthing bed mattresses manufactured by Huntleigh Healthcare - A risk of cross-infection from contaminated mattress cores. | 17/04/2008 |
| Select | NICAS-53 | MDEA(NI)2008-026 | Frazier and Poole suction instruments used in surgery. Manufactured by ConMed Corporation. | Frazier and Poole suction instruments used in surgery. Manufactured by ConMed Corporation - The sterility of some Frazier and Poole suction instruments may be compromised due to inadequate sealing of their packaging. | 14/04/2008 |
| Select | NICAS-52 | MDEA(NI)2008-025 | Invasive blood pressure monitoring sets with trigger flush device manufactured by Smiths Medical | "Invasive blood pressure monitoring sets: LogiCal, NovaTrans and TranStar models with trigger flush device manufactured by Smiths Medical - An error in the manufacture of the trigger flush device can lead to over-infusion of fluid.
This may also cause falsely elevated blood pressure measurements." | 07/04/2008 |
| Select | NICAS-51 | MDEA(NI)2008-024 | Hospira butterfly winged needle infusion set – regular and intermittent. All batches manufactured pr | Hospira butterfly winged needle infusion set – regular and intermittent. All batches manufactured prior to April 2008 - Leakage of fluid during IV administration e.g. radiopharmaceuticals during radionuclide imaging procedures. | 07/04/2008 |
| Select | NICAS-50 | MDEA(NI)2008-023 | ALN retrievable inferior vena cava (IVC) filter | ALN retrievable inferior vena cava (IVC) filter - An increased risk of filter migration. | 01/04/2008 |
| Select | NICAS-49 | MDEA(NI)2008-022 | Hospital beds Eleganza Standard, Smart and Deluxe models supplied by Pegasus. | Hospital beds Eleganza Standard, Smart and Deluxe models supplied by Pegasus - the emergency backrest release function on these beds may fail or become stiff and difficult to operate leading to a risk of delay in performing CPR. | 27/03/2008 |
| Select | NICAS-47 | MDEA(NI)2008-020 | Folding shower seat 2000 Series manufactured by AKW Medi-Care Limited | Folding shower seat 2000 Series manufactured by AKW Medi-Care Limited - The shower seat supports can fail causing the user to fall. | 27/03/2008 |
| Select | NICAS-48 | MDEA(NI)2008-021 | Nursing beds. Models 3010 and 5020 manufactured by Volker. | Nursing beds. Models 3010 and 5020 manufactured by Volker - risk of asphyxiation or injury from entrapment of head, neck or chest in the bed rail’s gaps. | 27/03/2008 |
| Select | NICAS-46 | MDEA(NI)2008-019 | Patient turner, model 411973300, manufactured by Etac. | Patient turner, model 411973300, manufactured by Etac - Risk of head entrapment in the gap of the handle assembly. | 26/03/2008 |
| Select | NICAS-45 | MDEA(NI)2008-018 | Oral hygiene swabs – all manufacturers. | Oral hygiene swabs – all manufacturers. Foam heads of oral swabs may detach from the stick during use. This may present a choking hazard for patients. | 18/03/2008 |
| Select | NICAS-42 | MDEA(NI)2008-015 | Typhoon and Typhoon II battery powered wheelchairs manufactured by Invacare | Typhoon and Typhoon II battery powered wheelchairs manufactured by Invacare. The wheelchair is too heavy for any standard four point webbing tie-down system commercially available for use in a vehicle. | 18/03/2008 |
| Select | NICAS-43 | MDEA(NI)2008-016 | Patient transfer slides/boards, models LOCO-400A Duo and LOCO-401A Duo | Patient transfer slides/boards, models LOCO-400A Duo and LOCO-401A Duo manufactured by Select Healthcare (UK) Ltd. Transfer slides/boards are cracking and breaking. | 18/03/2008 |
| Select | NICAS-44 | MDEA(NI)2008-017 | Needle-free intravascular connectors. All brands. | Needle-free intravascular connectors. All brands. There is a risk of infection if the top/septum of the connector remains recessed within its housing. Swabbing of the connector in this condition may lead to inadequate decontamination. | 18/03/2008 |
| Select | NICAS-40 | MDEA(NI)2008-013 | Heel & Elbow and Heel & Ankle Gelbodies used to help prevent pressure ulcers. Manufactured by Trulif | Heel & Elbow and Heel & Ankle Gelbodies used to help prevent pressure ulcers. Manufactured by Trulife. Risk of broken skin, friction burns, and redness from using Heel & Elbow and Heel & Ankle Gelbodies over a period of prolonged continuous use. | 10/03/2008 |
| Select | NICAS-41 | MDEA(NI)2008-014 | Medical air plant: risks associated with critical component failure. | Medical air plant: risks associated with critical component failure. Two incidents have been reported involving failure of 4-bar medical air plant due to a fault in the central control unit (CCU) printed circuit board (PCB) and motor control unit (MCU) PCB with fuses. This resulted in the loss of all three medical air compressors for over 24 hours, requiring the hospital to use the emergency reserve manifold (ERM) and secure sufficient replacement medical air cylinders to meet demand. | 10/03/2008 |
| Select | NICAS-39 | MDEA(NI)2008-012 | Medication cassette reservoir for CADD Legacy and CADD Prizm infusion pumps manufactured by Smiths M | "Medication cassette reservoir for CADD® Legacy and CADD® Prizm infusion pumps manufactured by Smiths Medical. Model numbers 21-7001-24, 21-7002-24 and 21-7100-24. Lot numbers 023X17 to 122X17 inclusive.
Manufacturing fault that may allow leakage from, or entry of air into, specific lot numbers of medication cassette reservoir." | 05/03/2008 |
| Select | NICAS-38 | MDEA(NI)2008-011 | Automated peritoneal dialysis systems. | "Automated peritoneal dialysis systems.
Homechoice/Homechoice Pro (Baxter Healthcare Ltd). A potential for the unrecorded delivery of infused fluid during treatment." | 03/03/2008 |
| Select | NICAS-37 | MDEA(NI)2008-010 | Ambulift hoist. All models manufactured by Arjo or Mechanaids. | Ambulift hoist. All models manufactured by Arjo or Mechanaids. Risk of the occupant slipping from the seat during use. | 03/03/2008 |
| Select | NICAS-36 | MDEA(NI)2008-009 | Blood coagulation test - SmartCheck INR system manufactured by Unipath Ltd. | Blood coagulation test - SmartCheck INR system manufactured by Unipath Ltd. Risk of inaccurate results leading to incorrect dosing of anticoagulant therapy | 28/02/2008 |
| Select | NICAS-35 | MDEA(NI)2008-008 | Hill-Rom Avantguard 1200 and 1400 with manually operated lock-out function | Hill-Rom Avantguard 1200 and 1400 with manually operated lock-out function - Lack of use of the manual lock-out function has lead to fatalities from crush injuries. | 22/02/2008 |
| Select | NICAS-34 | MDEA(NI)2008-007 | Stretchers/trolleys manufactured by Stryker Medical. | Stretchers/trolleys manufactured by Stryker Medical - the brake mechanism used on some models may not lock due to a component failure or excessive wear. | 14/02/2008 |
| Select | NICAS-32 | MDEA(NI)2008-005 | Hard-shell venous reservoirs and oxygenators used for cardiopulmonary bypass during heart surgery: v | "Hard-shell venous reservoirs and oxygenators used for cardiopulmonary bypass during heart surgery: various manufacturers - • | 13/02/2008 |
| Select | NICAS-33 | MDEA(NI)2008-006 | Blood glucose meters and test strips. | Blood glucose meters and test strips:- The OneTouch Ultra test strips may generate incorrect results when used in conjunction with the MediSense Optium, Optium Xceed or Boots brand meters. | 13/02/2008 |
| Select | NICAS-31 | MDEA(NI)2008-004 | Umbilical cord clamp clipper manufactured by Unomedical Ltd. Product reference: 84006182 - Affected | "Umbilical cord clamp clipper manufactured by Unomedical Ltd. Product reference: 84006182 - Affected lot number: 163136.
There is the potential for the blade to fall out of this device or break during use. This is an expansion of a recall previously carried out in November 2006, and referred to in MDEA(NI)2007 – 036." | 31/01/2008 |
| Select | NICAS-30 | MDEA(NI)2008-003 | Total knee replacement implants - manufacturing issue | "Total knee replacement implants.
VKS, RT- Plus and TC- Plus femoral and tibial knee components manufactured by Plus Orthopaedics/Smith & Nephew Orthopaedics Ltd (specific lot numbers).
Extension of recall of implants which may have incorrect alloy composition." | 17/01/2008 |
| Select | NICAS-29 | MDEA(NI)2008-002 | Birthing beds. Huntleigh Healthcare Birthright and Hoskins Birthcare. | Huntleigh Healthcare - birthing beds - Birthright and Hoskins Birthcare. These beds can become unstable and tip if patients, visitors or staff sit or kneel near the foot end of the bed. | 17/01/2008 |
| Select | NICAS-28 | MDEA(NI)2008-001 | 2008 Guidance for the reporting of adverse incidents to the NIAIC. | Under-reporting of medical device and estates related adverse incidents to the Northern Ireland Adverse Incident Centre. | 04/01/2008 |
| Select | NICAS-27 | MDA-2007-095 | (APC Medical Ltd) the manufacturer has found potential for rapid pacing while switching off this tem | external temporary cardiac pacemaker (bedside model 4170 serial numbers 1 - 998) - return these to manufacturer and ensure rapid pace switch is off before you shut the device down | 06/12/2007 |
| Select | NICAS-25 | MDA-2007-045 | Optima XL stubby handle and laryngoscope handle - delays to intubation | (Timesco of London Ltd.) possibility that poor contact between Timesco stubby handles and Timesco laryngoscope blades (models: 3000.308.10 and 3000.308.10T) may result in the bulb not being lit with subsequent delays to intubation. | 04/06/2007 |
| Select | NICAS-23 | MDA-2007-040 | Primus anaesthetic workstation - ensure the backup oxygen cylinder’s non-interchangeable screw threa | (Draeger Medical UK Ltd) report of an incorrect connection of the backup oxygen cylinder, which would prevent backup oxygen supply if the oxygen pipeline failed. | 23/05/2007 |
| Select | NICAS-22 | MDA-2007-034 | Flexible endoscopes - avoid placing device in storage and drying cabinets where ultraviolet light sh | (Olympus) outer sheath and light guide tube of endoscopes may be damaged if directly exposed to ultraviolet (UV) light used in some endoscope storage and drying cabinets. | 10/05/2007 |
| Select | NICAS-20 | MDA-2007-023 | Vitality and Assure implantable cardioverter defibrillator (ICD) families and Contak Renewal cardiac | (Boston Scientific Ltd.) patients may experience extended charge times in the middle-of-life phase of the device, which could lead to a delay in shock delivery; also replacement and end of life indicators may display earlier than expected. | 13/03/2007 |
| Select | NICAS-19 | MDA-2006-066 | Lancing devices used in nursing homes and care homes - correction to list of disposable single-use l | (All) MHRA continues to receive reports of hepatitis B outbreaks in nursing homes and care homes, which is linked with single-use lancing devices being used on multiple patients. | 06/12/2006 |
| Select | NICAS-18 | MDA-2006-065 | Medical pacemakers (Identity SR model 5172, Identity DR model 5370 and Identity XL DR model 5376) - | (St Jude Medical UK Ltd) a programmer software anomaly can occur when these devices are used together, which can cause inaccurate display of battery voltage, battery longevity and elective replacement indicator (ERI) status. | 23/11/2006 |
| Select | NICAS-17 | MDA-2006-055 | Hand pieces used with oral / maxillofacial surgery drills - ensure maintenance procedures are in pla | (General) significant increase in the number of reports from patients receiving oral burns from hand pieces used with overheated drills mostly due to lack of appropriate maintenance. | 21/09/2006 |
| Select | NICAS-16 | MDA-2006-038 | Implantable pacemaker and implantable defibrillator families (INSIGNIA, NEXUS, CONTAK RENEWAL TR, CO | (Guidant) recall of subset of implantable pacemakers and defibrillators due to component failure that may lead to malfunction or premature depletion of battery. | 13/07/2006 |
| Select | NICAS-13 | MDA-2005-072 | Sigma® implantable pacemakers - advise patients to contact their follow-up clinic immediately if the | (Medtronic) failure of interconnecting wires may cause loss of pacing output from atrial and or ventricular ports, premature depletion of battery, intermittent or total loss of telemetry, undersensing, high lead impedance values, loss of rate response, device reset to manufacturer's default settings. | 21/12/2005 |
| Select | NICAS-12 | MDA-2005-070 | INSIGNIA and NEXUS implantable pacemakers - recall | (Guidant) component failure. | 19/12/2005 |
| Select | NICAS-11 | MDA-2005-067 | INSIGNIA and NEXUS implantable pacemakers - consider replacement of elective device if there are one | (Guidant) device may have intermittent or permanent loss of pacing output without warning, intermittent permanent loss of telemetry, reversion to ventricular inhibited pacing (VVI), and/or reset warning message upon interrogation. | 08/12/2005 |
| Select | NICAS-8 | MDA-2005-037 | VENTAK PRIZM® 2 DR implantable cardioverter defibrillator (ICD) - ensure follow ups are within every | (Guidant) potential loss of cardioversion, defibrillation or pacing therapy of model 1861 due to diversion of high voltage shock. | 27/05/2005 |
| Select | NICAS-9 | MDA-2005-038 | CONTAK RENEWAL® (model H135) and CONTAK RENEWAL® 2 (model H155) implantable cardiac resynchronizatio | (Guidant) potential loss of cardioversion, defibrillation or pacing therapy due to diversion of high voltage shock. | 27/05/2005 |
| Select | NICAS-6 | MDA-2004-045 | Implantable cardioverter defibrillator (ICD) models GEM® DR 7271 and Micro Jewel® II 7223Cx - identi | (Medtronic) extended charge times and inability to deliver therapy for a subset of the above devices when battery voltages are close to elective replacement indicator (ERI). | 09/09/2004 |
| Select | NICAS-5 | MDA-2004-019 | Implantable defibrillators - follow up with patients given these devices | (Medtronic) Marquis VR 7230, Marquis DR 7274, InSync Marquis 7277; potential battery defect; possible rapid depletion. | 26/04/2004 |
| Select | NICAS-4 | MDA-2003-044 | Transilluminators used with neonates - ensure you follow the instructions and that the device can be | (All) use of an inappropriate light source for transillumination can result in burns. | 02/12/2003 |
| Select | NICAS-1 | MDA-2003-008 | External pacemakers - sudden increase in pacing rate and change of mode | (APC Medical Ltd) the pacing rate for models E4162, E4164, E4165 and E4166 may increase by 20 pulses per minute and change in pacing mode in some cases. | 27/03/2003 |