My HPRA: Register

Safety communications

This page is for patients, the public and healthcare professionals.

It describes the different communications issued for device safety issues.

How is device safety information communicated?

There are two main types of safety communications:

  1. Field safety notices (FSNs), published by manufacturers.
  2. HPRA safety notices (SNs), published by us.

For more details on these communications, click the menu below. 

Field safety notices

Manufacturers must inform device users if they find a safety issue with their device.

Manufacturers issue FSNs to device users if they find a safety issue.

If your device is affected by a safety issue and you receive a FSN, read it carefully and follow the instructions.

FSNs may have key information or actions, such as:

  • Removal of a device from the market.
  • Updated instructions on how to use a device safely.
  • A patient recall (where patients are to be brought back for re-testing).

We publish a summary of FSNs affecting the Irish market during the first week of each month.

We also publish a list of FSNs circulated to the Irish market where actions remain outstanding.

We can only publish FSNs notified to us.

If you receive an FSN not on our list, please let us know by email at devicesafety@hpra.ie.

 

 

HPRA safety notices

If you receive a FSN from a manufacturer, act on it at once.

Do not wait for a HPRA safety notice . Most FSNs are not accompanied by a HPRA safety notice.

We issue HPRA safety notices to device users when we consider it necessary.

This includes:

  • To give more information to users in Ireland (FSNs often accompany SNs).
  • To raise awareness of a high risk FSN.
  • To raise awareness of an FSN where the manufacturer has not been able to contact all device users.
  • Where a company no longer exists.

More details on our safety notices, including how they are formatted, can be found here.

Anyone can sign up to receive HPRA safety notice by emailing devicesafety@hpra.ie.

What should I do if I receive a HPRA safety notice?

If you are a patient or member of the public, you should:

  • Review the safety notice.
  • Discuss any problems or concerns with your doctor.

If you are a healthcare professional, you should:

  • Ensure the notice reaches the correct person in your organisation.
  • Share the notice with other affected organisations or persons.
  • Review the notice and complete actions as needed.

 



Date Title Type
28/04/2017 Healon, Healon GV, Healon 5 Pro, Healon Pro. Priority 2 – Warning Warning
04/04/2017 Summary of Field Safety Notices - March 2017 3rd Party Publications
03/04/2017 MiniMed 640G Insulin Pump. Priority 2 – Warning Warning
24/03/2017 HeartStart MRx Monitor/Defibrillator. Priority 2 – Warning Warning
20/03/2017 Risks associated with medical devices containing chlorhexidine / chlorhexidine gluconate. Priority 2 – Warning Warning
10/03/2017 LIFEPAK 1000 Defibrillator. Priority 2 – Warning Warning
06/03/2017 Freestyle Life Test Strips. Priority 2 – Warning Warning
02/03/2017 Summary of Field Safety Notice – February 2017 3rd Party Publications
27/02/2017 AIRVO 2 / myAIRVO 2 Humidifiers. Priority 2 – Warning Warning
24/02/2017 ID-DiaCells (Multiple Products). Priority 2 – Warning Warning
22/02/2017 Reyoungel Dermal Filler - Priority 2 - Warning Warning
16/02/2017 Oxylog 3000 and Oxylog 3000 plus Ventilators. Priority 2 – Warning Warning
16/02/2017 Disposable STA®-Cuvettes (Ref. 38669) For Haemostasis Analysers STA-R®, STA R MAX®, STA COMPACT®, STA COMPACT MAX®. Priority 2 – Warning Warning
09/02/2017 Caution when Purchasing Dental Devices Online - Information Notice Advisory
08/02/2017 ETEST® COLISTIN. Priority 2 – Warning Warning
02/02/2017 Summary of Field Safety Notice – January 2017 3rd Party Publications
31/01/2017 VITEK®2 AST-YS01 Test Kit, VITEK®2 AST-YS07 Test Kit. Priority 2 – Warning Warning
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
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