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
25/02/2014 Liko FreeSpan Traverse & FreeSpan Ultra Twin Traverse Freestanding Lift Systems Advisory
21/02/2014 ARCHITECT Intact PTH Assay Reagents, Calibrators and Controls Advisory
21/02/2014 FreeStyle Mini® and FreeStyle® Blood Glucose Monitoring Systems Advisory
20/02/2014 Puma, Beatle, Alex & Ibis XP Power Wheelchairs Advisory
19/02/2014 Kodak 2100 and 2200 Advisory
11/02/2014 MINISEND-LUER LOCK CAP Advisory
11/02/2014 BD Plastipak™ 50mL Luer Lok Syringes with Syringe Pumps Advisory
17/12/2013 Patterson Walking Sticks - 404 Model Advisory
17/12/2013 Patterson Walking Frames (wheeled and non-wheeled) Advisory
08/11/2013 NIPPY 3 ventilator, NIPPY JUNIOR ventilator, NIPPY ST ventilator, NIPPY S ventilator Advisory
18/09/2013 Zimma Walking Frames fitted with Wheeled Extension Legs Advisory
17/09/2013 Birdie & Flamingo Patient Lifters Advisory
02/09/2013 HeartStart XL with M3516A batteries of lot number prefix ‘LK’ Advisory
30/07/2013 Trophy IRIX 70, IRIX 708, NOVELIX 6510 and ORAMATIC 558 Advisory
11/07/2013 SynchroMed® II and SynchroMed EL Implantable Drug Pumps Advisory
13/06/2013 Gas Tamponades: EasyGas; SF6, C2F6, C3F8 Advisory
17/05/2013 LIFEPAK CR Plus and LIFEPAK EXPRESS Advisory
15/04/2013 OneTouch Verio Pro and OneTouch Verio IQ Blood Glucose Meters Advisory
27/03/2013 ALL HOSPIRA GEMSTAR FAMILY OF INFUSERS Advisory
26/03/2013 ALL HOSPIRA PLUM A+/A+3 FAMILY OF INFUSERS Advisory