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
03/05/2018 Jaundice Meters JM-103, JM-105. Priority 2 – Warning Warning
02/05/2018 BD Vacutainer® EDTA & Lithium Heparin blood collection tubes - IFU update. Priority 2 – Warning Warning
02/05/2018 Summary of Field Safety Notice – April 2018 3rd Party Publications
01/05/2018 BD Posiflush™ Heparin Lock Flush Syringes & BD™ Pre-filled Normal Saline Syringes. Priority 1 – For Immediate Action For Immediate Action
05/04/2018 Summary of Field Safety Notices - March 2018 3rd Party Publications
03/04/2018 T34 Ambulatory Syringe Pumps. Priority 2 – Warning Warning
07/03/2018 Summary of Field Safety Notice – February 2018 3rd Party Publications
07/02/2018 Head Lice Treatment Products – Risk of Fire. Priority 2 – Warning Warning
05/02/2018 CADD Medication Cassette Reservoirs (Non Flow-Stop), 50ml and 100ml. Priority 2 – Warning. Warning
02/02/2018 Zimmer Biomet Various Hip and Knee Implants (Ref: ZFA 2017-510). Priority 2 – Warning Warning
01/02/2018 VIDAS and mini VIDAS. Priority 2 – Warning Warning
01/02/2018 Summary of Field Safety Notice – January 2018 3rd Party Publications
29/01/2018 HPRA Information Notice - Food Intolerance Testing - 2018 Update Advisory
26/01/2018 Medtronic MiniMed Infusion Sets. Priority 1 – For Immediate Action For Immediate Action
24/01/2018 Animas Vibe Insulin Pumps. Priority 3 – Advisory. Advisory
24/01/2018 COULTER EPICS XL COULTER EPICS XLMCL and FC 500 Series Flow Cytometers. Priority 2 – Warning. Warning
12/01/2018 Dispenser Issues with Hematoxylin II and Horseradish Peroxidase Reagents. Priority 2 – Warning Warning
03/01/2018 Summary of Field Safety Notices - December 2017 3rd Party Publications
21/12/2017 ETEST® Teicoplanin 256 (TP) SPB and Foam packaging. Priority 2 – Warning Warning
20/12/2017 VALITUDE™ CRT-P, ACCOLADE™ Pacemakers, VISIONIST™ CRT-P, PROPONENT™ Pacemakers, ALTRUA™ 2 Pacemakers (see Product name for full device name) Warning