Safety Notices

HPRA Safety Notice Communication

We publish notices relating to the safety and/or quality of medical devices. The issues covered by these notices will range from quality defect information to product recalls, to updated information on the appropriate usage of the medical devices.

View the current safety notices for medical devices below.

If you would like to receive copies of these notices at the time of publication via e-mail please forward an e-mail request to devicesafety@hpra.ie.

Learn more about HPRA safety notices.

Manufacturer's Field Safety Notices

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market.

The HPRA puts these notices on our website for information.

Learn more about field safety notices.

Field Safety Notices - Outstanding Actions

When a field safety notice is issued by a medical device manufacturer on the Irish market, the HPRA seek confirmation from the manufacturer that the required action has been completed. Sometimes, completion of the action is delayed or hampered due to issues experienced by the manufacturer. The HPRA publishes details of field safety notices that have been circulated to the Irish market for which action remains outstanding.

Learn more about field safety notices.

Date Title Type
04/08/2015 Animas Vibe Insulin Infusion Pump. Priority 2 – Warning Warning
17/07/2015 SureFlex™ Reusable Fibers and Reusable Stripper and Cleaver Accessories. Priority 1 – For Immediate Action For Immediate Action
15/07/2015 Sterile Forceps. Priority 1 – For Immediate Action For Immediate Action
07/07/2015 SOMNOventCR and prismaCR. Priority 2 – Warning Warning
02/07/2015 Summary of Field Safety Notices - June 2015 3rd Party Publications
18/06/2015 CRIT-LINE® Blood Chamber. Priority 2 – Warning Warning
12/06/2015 Derma C - Priority 2 – Warning Warning
05/06/2015 Devon Light Gloves All lot numbers with 508xxxx or lower. Priority 2 – Warning Warning
04/06/2015 Summary of Field Safety Notice – May 2015 3rd Party Publications
02/06/2015 Philips ventilators BiPAP autoSV, BiPAP autoSV Advanced, OmniLab Advanced, OmniLab Advanced + and HeartPAP devices. Priority 2 – Warning Warning
26/05/2015 OxiMax N-65 and N560 Pulse Oximeters. Priority 2 – Warning Warning
25/05/2015 Specific ResMed Ventilators with Adaptive ServoVentilation (ASV). Priority 2 – Warning Warning
21/05/2015 Interference Of N-Acetylcysteine (NAC) with Enzyme-based Assays Used following Paracetamol Overdose. Priority 3 - Advisory Advisory
20/05/2015 Accu-Chek Spirit and Accu-Chek Spirit Combo Insulin Pumps. Priority 2 – Warning Warning
15/05/2015 Medtronic Synchromed II Implantable Infusion Pump Systems Advisory
14/05/2015 AVEA Ventilator. Priority 2 – Warning Warning
06/05/2015 Summary of Field Safety Notices - April 2015 3rd Party Publications
02/04/2015 Summary of Field Safety Notices - March 2015 3rd Party Publications
25/03/2015 Hypersensitivity and hypersensitivity-like reactions with FX CorDiax dialysers - Priority 2 – Warning Warning
24/03/2015 HPRA Information Notice - Food Intolerance Testing Advisory