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
30/01/2017 BD Plastipak™ Syringe, Catheter tip with Luer slip adaptor. Priority 2 – Warning Warning
27/01/2017 INNOVANCE D-Dimer on Sysmex CS Systems. Priority 2 – Warning Warning
17/01/2017 Romed 2-part syringes, 20 ml (Ref Number: SYR-20ML) Lots: 150608, 151015, 151204, 160202. Priority 2 – Warning Warning
16/01/2017 SynchroMed® II Implantable Infusion Pumps. Priority 2 – Warning Warning
04/01/2017 Summary of Field Safety Notices - December 2016 3rd Party Publications
21/12/2016 Life-Point Pro AED / bPLUS / mPLUS defibrillator devices and Adult Electrode Pads & Paediatric Electrode Pads. Priority 1 – Immediate Action For Immediate Action
15/12/2016 LMA® Mucosal Atomization Devices and LMA® MAD Nasal™ Intranasal Mucosal Atomization Devices. Priority 2 – Warning Warning
13/12/2016 Reflection Dead Blow Mallet. Priority 2 – Warning Warning
13/12/2016 Immucor Gamma Kleihauer Kit. Priority 2 – Warning Warning
13/12/2016 TOP-Q Super Fine Line TOP-Q Super Derm Line- Priority 2 Warning Warning
09/12/2016 CME T34 Ambulatory Syringe Pumps. Priority 3 – Advisory Advisory
05/12/2016 Summary of Field Safety Notice – November 2016 3rd Party Publications
05/12/2016 Multiple Ortho Reagent Red Blood Cell (RRBC) Products & - Control Reagent Products containing Red Blood Cells. Priority 2 – Warning Warning
29/11/2016 Laerdal Suction Unit when used with the LSU NiMH Battery at low temperatures. Priority 2 – Warning Warning
10/11/2016 Accu-Chek Aviva Combo, Accu-Chek Mobile bGM system, Accu-Chek Spirit Combo, Accu-Chek Spirit and Spirit Combo insulin pump. Priority 3 – Advisory Advisory
03/11/2016 EasySept Hydro Plus. Product Codes: 54085193‐120ML EASYSEPT Hydro Plus Starter kit.. 51085192‐360ML EASYSEPT Hydro Plus. 54085194‐3x360ML EASYSEPT Hydro Plus. Priority 1 – Immediate Action For Immediate Action
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