Medical device alerts archived in November 2021
Following our latest review of medical device alerts, we have archived the ones listed below.
| Reference | Title |
|---|---|
| Novaline haemodialysis bloodlines used with Baxter/Gambro haemodialysis machines – Recall of specific products | |
| First generation JOURNEY BCS Knee System– Higher than expected risk of revision | |
| Orthopaedic bone plates and cortical screws: ADVANSYS MLP-DLP; ADVANSYS TTC; Large QWIX; TIBIAXYS and UNI-CP–Sterile – Risk of infection | |
| BenchMark Automated Slide Stainer series – FLO LOK III Reagent Dispenser Issue for IHC and ISH kits including INFORM HPV III Family 16 Probe (B). | |
| Flex connectors in Halyard Closed Suction Kits – risk of interruption of ventilation | |
| SureSigns VS & VM patient monitors and Viewing stations manufactured before 3 May 2018- risk of batteries overheating or igniting | |
| Various trauma guide wires – risk of infection due to packaging failure | |
| CoaguChek Test Strips for Point of Care and Home Use – risk of false high results | |
| Suction catheters, gastro-enteral tubes, intermittent urology cathetersand sterile urine drainage bags – potential breach in sterile barrier packaging | |
| Nellix Endovascular Aneurysm Sealing (EVAS) System - Device recall and enhanced patient surveillance | |
| Orthopaedic implant rHead Radial Head and Uni-Elbow: risk of early loosening | |
| Ophthalmic implant Raindrop Near Vision Inlay – risk of corneal haze. | |
| Professional use monitor/defibrillator: LIFEPAK 15 – risk of device failure during patient treatment and possible failure to deliver therapy | |
| Multi parameter patient monitors: Carescape B450, B650, B850, B20, B40, B20i, B40i, B125, B105, Dash 3000,4000,5000, Solar 8000M/i, 9500 | |
| Potentially breached sterile packaging of: rectal tubes, Unoversal drainage systems, SimpaVac, sterile suction connecting tubes, sterile connecting pieces, suction handles/sets (FilterFlowâ„¢/Deltaflo), oxygen catheters, sterile nasal oxygen cannulas, sterile oxygen connecting tubes, and sterile forceps. | |
| All T34 ambulatory syringe pumps need a sponge pad fitted to the battery compartment to prevent battery connection issues | |
| enFlow® IV fluid and blood warmer - risk of unsafe levels of aluminium leaching from the device – updated safety advice from manufacturer | |
| 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 | |
| Updated: Nellix Endovascular Aneurysm Sealing (EVAS) System - Device recall and enhanced patient surveillance | |
| Deltec Gripper non-coring needles and PORT-A-CATH trays containing Gripper needles – recall due to risk of needle occlusion | |
| Kiwi Complete Vacuum Delivery System – risk of failure to achieve or maintain vacuum during use (specific lot affected) | |
| Specific Hudson RCI Sheridan endotracheal tubes and connectors - 15 mm connector may detach from the tube before or during use | |
| Alarisâ„¢ Gateway Workstation and Alarisâ„¢ Gateway Workstation web browser user interface | |
| Natus gold cup electrodes and snap electrode leads – risk of electric shock | |
| Recall of Medicina IV Luer Slip syringe (IVS03) batch number 19040303 | |
| ApexPro telemetry server – risk of loss of alarms for ECG and pulse oximetry monitoring | |
| Arrow EZ-IO intraosseous vascular access needle sets – risk of needle stick injury | |
| NIPPY ventilator range (all models) – update to instructions for use | |
| Convex two-piece skin barriers (Natura /Surfit /Combihesive Wafers) for use with ostomy bags – recall due to risk of stoma injury, bleeding and leakage under the skin barrier | |
| Professional use defibrillator/monitor: all HeartStart XL+ (Model number 861290) - risk of failure to deliver therapy | |
| Skin preparation electrode gel: recall of all lots of LemonPrep, PediaPrep, Wave Prep and Cardio Prep due to risk of contamination and transmission of infection | |
| t: slim X2 insulin pump – discard or destroy defective mains (A/C) power adapters | |
| Self-expanding stents (S.M.A.R.T. and PRECISE) under MRI – various risks if MRI is operated outside the required conditions for these stents | |
| Pilling Clear Advantage aortic punch – risk of infection due to packaging failure | |
| Philips Respironics V60 ventilator – potential unexpected shutdown leading to complete loss of ventilation | |
| Masks: type IIR from Cardinal Health – destroy affected lots |
Updates to this page
Published 9 November 2021