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
06/11/2014 Insulin Infusion Pumps. Priority 3 – Advisory Advisory
11/08/2014 ArjoHuntleigh lifting poles with an adjustable strap and handle. Priority 3 – Advisory Advisory
06/08/2014 Magnetic Resonance Imaging Safety. Priority 3 – Advisory Advisory
25/06/2014 “Intended Purpose” of a Medical Device. Guidance for healthcare settings -Priority 3 – Advisory Advisory
23/06/2014 Alaris® SmartSite® Needle-Free Valve. Product Reference: 2000E7D. Priority 2 – Recall Advisory
05/06/2014 Accu-Chek® Mobile blood glucose monitoring system Priority 2 – Warning Advisory
15/05/2014 Illegal “iCARE” self test kits. Priority 2 – Warning Advisory
09/05/2014 pH Indicator Strips (non-bleeding) pH 0-6.0 & 2.0-9.0 Priority 2 – Warning Caution In Use Advisory
06/05/2014 Kryo range of freezers. Priority 2 – Warning Advisory
30/04/2014 Graseby Syringe Drivers (MS16A & MS26). Priority 2 – Warning. Caution In Use Advisory
29/04/2014 B.Braun Infusomat & Perfusor Space Infusion Pumps & Pole Clamps. Priority 2 - Warning Advisory
31/03/2014 New Format of IMB Safety Notices. Priority 3 - Advisory Advisory
31/03/2014 HeartStart MRx Monitor/Defibrillator Advisory
27/03/2014 SynchroMed® II Implantable Drug Pumps Advisory
24/03/2014 Accu-Chek Spirit Combo insulin pump (Pumps with serial numbers in the range 10171897 to 10281629 inclusive) Advisory
18/03/2014 samaritan® PAD 500P (Public Access Defibrillator) Advisory
14/03/2014 HomeChoice/HomeChoice PRO Automated PD System Advisory
14/03/2014 Pegasus Alternating Mattresses X2 Capacitor Upgrade Program Advisory
28/02/2014 BD Vacutainer Multiple Sample Luer Adaptor. Catalogue number: 367300 Advisory
27/02/2014 Applix Smart & Applix Vision Nutrition Pumps Serial numbers from 1998xxxx to 2010xxx Advisory