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
02/11/2016 Summary of Field Safety Notices - October 2016 3rd Party Publications
26/10/2016 LIFEPAK 1000 Defibrillator. Priority 2 – Warning Warning
26/10/2016 LIFEPAK CR Plus AED and LIFEPAK EXPRESS AEDs. Priority 2 – Warning Warning
18/10/2016 Liko® Viking® L, Viking® M, Viking® XL, and Viking® 300 Mobile Lifts. Priority 2 – Warning Warning
13/10/2016 Implantable Cardioverter Defibrillator: St. Jude Medical Fortify™, Fortify Assura™, Quadra Assura™, Quadra Assura MP™, Unify™, Unify Assura™ and Unify Quadra™. Priority 1 – For Immediate Action For Immediate Action
12/10/2016 Use of Luer adaptors with Needle-free Connection Systems and Glass Pre-filled Syringes. Priority 2 – Warning Warning
06/10/2016 Animas Vibe Insulin Infusion Pumps. Priority 2 – Warning Warning
03/10/2016 Summary of Field Safety Notice – September 2016 3rd Party Publications
23/09/2016 Beacon Tip Angiographic Catheters / William Cook Procedure packs. Priority 2 – Warning Warning
21/09/2016 Spinocath® Models: 4517717 & 4517725. Priority 1 – For Immediate Action For Immediate Action
19/09/2016 Klerpack BD Syringe Multi-Pack. Priority 1 – For Immediate Action For Immediate Action
16/09/2016 Comfort Shield Barrier Cream Cloths. Priority 2 – Warning Warning
12/09/2016 Klerpack BD Syringe Multi-Pack. Priority 1 – For Immediate Action For Immediate Action
01/09/2016 Summary of Field Safety Notices - August 2016 3rd Party Publications
24/08/2016 W11054 Columbia Blood Agar 90m Double Wrap - lot 0034509324, W11305 Columbia Blood Agar + Neomycin - lot 0115510360, W11340 Streptococcus Medium - lot 0704570133, W11050 Columbia Blood Agar - lots 0035511425 & 0034572725. Priority 2 – Warning Warning
15/08/2016 ETEST® COLISTIN. Priority 2 – Warning Warning
05/08/2016 Flocare Infinity Enteral Feeding Pumps. Priority 2 – Warning Warning
05/08/2016 Immucor Gamma Kleihauer Kit. Priority 2 – Warning Warning
04/08/2016 VITEK®2 AST-YS07 Test Kit. Priority 2 – Warning Warning
03/08/2016 Summary of Field Safety Notice – July 2016 3rd Party Publications