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
14/07/2017 VITEK® 2 Gram-Negative AST cards. Priority 2 – Warning Warning
13/07/2017 Birdie Lifter. Priority 2 – Warning. Warning
13/07/2017 VITEK® 2 Identification / Antimicrobial Susceptibility Test Cards. Priority 2 – Warning. Warning
05/07/2017 NovoPen Echo® and NovoPen® 5 Insulin Pens. Priority 1 – For Immediate Action For Immediate Action
04/07/2017 Summary of Field Safety Notice – June 2017 3rd Party Publications
04/07/2017 Field Safety Notice Summary Sheet - Outstanding Actions 3rd Party Publications
27/06/2017 CS100, CS100i and CS300 Intra-Aortic Balloon Pumps. Priority 2 – Warning Warning
27/06/2017 Micro-Needling devices and Needle Cartridges Priority 2 – Warning Warning
07/06/2017 MiniMed 640G Insulin Pump. Priority 2 – Warning Warning
01/06/2017 Summary of Field Safety Notices - May 2017 3rd Party Publications
30/05/2017 Alaris™ GS, GH, CC, TIVA, PK, Enteral Syringe Pumps & Asena™ GS, GH, CC, TIVA, PK Syringe Pumps. Priority 2 – Warning Warning
26/05/2017 Aqua secret Dermal Filler - Priority 2 – Warning Warning
18/05/2017 V60 VENTILATORS MANUFACTURED BEFORE 15 SEPTEMBER 2015. Priority 2 – Warning Warning
03/05/2017 Summary of Field Safety Notice – April 2017 3rd Party Publications
28/04/2017 Healon, Healon GV, Healon 5 Pro, Healon Pro. Priority 2 – Warning Warning
04/04/2017 Summary of Field Safety Notices - March 2017 3rd Party Publications
03/04/2017 MiniMed 640G Insulin Pump. Priority 2 – Warning Warning
24/03/2017 HeartStart MRx Monitor/Defibrillator. Priority 2 – Warning Warning
20/03/2017 Risks associated with medical devices containing chlorhexidine / chlorhexidine gluconate. Priority 2 – Warning Warning
10/03/2017 LIFEPAK 1000 Defibrillator. Priority 2 – Warning Warning