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
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
19/12/2017 ARCHITECT c4000 / c8000 / c16000 Cuvette Segments. Priority 2 – Warning Warning
15/12/2017 Leakage of Administration Sets when used with FLOLAN pH12 (Epoprostenol Sodium). Priority 2 – Warning Warning
14/12/2017 Thermo Scientific™ Remel™ Shigella sonnei (Phases 1&2) Agglutinating Serum. Priority 2 – Warning Warning
11/12/2017 SynchroMed® II Implantable Drug Pumps. Priority 2 – Warning. Warning
01/12/2017 Summary of Field Safety Notice – November 2017 3rd Party Publications
17/11/2017 CADD® Medication Cassette Reservoirs (Non Flow-Stop), 50ml and 100ml. Priority 2 – Warning. Warning
09/11/2017 Alaris/Asena GS, GH, CC, TIVA, PK, Syringe Pumps Manufactured before September 2008. Priority 2 – Warning Warning
02/11/2017 Summary of Field Safety Notices - October 2017 3rd Party Publications
27/10/2017 MAXTER ENTRAL* ENFit® NASOGASTRIC (NG) FEEDING TUBES. Priority 1 – For Immediate Action For Immediate Action
27/10/2017 CT Imaging of Patients reliant on Electronic Medical Devices Advisory
27/10/2017 MR Imaging of Patients with Implanted Medical Devices Advisory
26/10/2017 VITEK® 2 Gram- Positive Identification Test Kit. Priority 2 – Warning. Warning
19/10/2017 Liko Universal Slingbar 350, Slingbar 450, and Slingbar 600. Priority 2 – Warning Warning
06/10/2017 Mobile Applications in Healthcare - Information Notice Advisory
03/10/2017 Field Safety Notice – September 2017 3rd Party Publications