Medical device alerts archived in November 2021
Following our latest review of medical device alerts, we have archived the ones listed below.
| Reference | Title |
|---|---|
| MDA/2018/025R | Novaline haemodialysis bloodlines used with Baxter/Gambro haemodialysis machines – Recall of specific products |
| MDA/2018/026 | First generation JOURNEY BCS Knee System– Higher than expected risk of revision |
| MDA/2018/028 | Orthopaedic bone plates and cortical screws: ADVANSYS MLP-DLP; ADVANSYS TTC; Large QWIX; TIBIAXYS and UNI-CP–Sterile – Risk of infection |
| 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). |
| MDA/2018/030 | Flex connectors in Halyard Closed Suction Kits – risk of interruption of ventilation |
| MDA/2018/031 | SureSigns VS & VM patient monitors and Viewing stations manufactured before 3 May 2018- risk of batteries overheating or igniting |
| MDA/2018/032 | Various trauma guide wires – risk of infection due to packaging failure |
| MDA/2018/033 | CoaguChek Test Strips for Point of Care and Home Use – risk of false high results |
| MDA/2018/034 | Suction catheters, gastro-enteral tubes, intermittent urology cathetersand sterile urine drainage bags – potential breach in sterile barrier packaging |
| MDA/2019/002 | Nellix Endovascular Aneurysm Sealing (EVAS) System - Device recall and enhanced patient surveillance |
| MDA/2019/006 | Orthopaedic implant rHead Radial Head and Uni-Elbow: risk of early loosening |
| MDA/2019/007 | Ophthalmic implant Raindrop Near Vision Inlay – risk of corneal haze. |
| MDA/2019/010 | Professional use monitor/defibrillator: LIFEPAK 15 – risk of device failure during patient treatment and possible failure to deliver therapy |
| MDA/2019/011 | Multi parameter patient monitors: Carescape B450, B650, B850, B20, B40, B20i, B40i, B125, B105, Dash 3000,4000,5000, Solar 8000M/i, 9500 |
| MDA/2019/012 | Potentially breached sterile packaging of: 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. |
| MDA/2019/013 | All T34 ambulatory syringe pumps need a sponge pad fitted to the battery compartment to prevent battery connection issues |
| MDA/2019/016 | enFlow® IV fluid and blood warmer - risk of unsafe levels of aluminium leaching from the device – updated safety advice from manufacturer |
| 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 |
| MDA/2019/021 | Updated: Nellix Endovascular Aneurysm Sealing (EVAS) System - Device recall and enhanced patient surveillance |
| MDA/2019/029 | Deltec Gripper non-coring needles and PORT-A-CATH trays containing Gripper needles – recall due to risk of needle occlusion |
| MDA/2019/031 | Kiwi Complete Vacuum Delivery System – risk of failure to achieve or maintain vacuum during use (specific lot affected) |
| MDA/2019/036 | Specific Hudson RCI Sheridan endotracheal tubes and connectors - 15 mm connector may detach from the tube before or during use |
| MDA/2019/040 | Alaris™ Gateway Workstation and Alaris™ Gateway Workstation web browser user interface |
| MDA/2019/042 | Natus gold cup electrodes and snap electrode leads – risk of electric shock |
| MDA/2019/043 | Recall of Medicina IV Luer Slip syringe (IVS03) batch number 19040303 |
| MDA/2019/045 | ApexPro telemetry server – risk of loss of alarms for ECG and pulse oximetry monitoring |
| MDA/2019/046 | Arrow EZ-IO intraosseous vascular access needle sets – risk of needle stick injury |
| MDA/2020/001 | NIPPY ventilator range (all models) – update to instructions for use |
| MDA/2020/002 | 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 |
| MDA/2020/003 | Professional use defibrillator/monitor: all HeartStart XL+ (Model number 861290) - risk of failure to deliver therapy |
| MDA/2020/004 | 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 |
| MDA/2020/005 | t: slim X2 insulin pump – discard or destroy defective mains (A/C) power adapters |
| MDA/2020/006 | 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 |
| MDA/2020/014 | Pilling Clear Advantage aortic punch – risk of infection due to packaging failure |
| MDA/2020/017 | Philips Respironics V60 ventilator – potential unexpected shutdown leading to complete loss of ventilation |
| MDA/2020/021R | Masks: type IIR from Cardinal Health – destroy affected lots |
Published 9 November 2021