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
05/02/2018 CADD Medication Cassette Reservoirs (Non Flow-Stop), 50ml and 100ml. Priority 2 – Warning. Warning
02/02/2018 Zimmer Biomet Various Hip and Knee Implants (Ref: ZFA 2017-510). Priority 2 – Warning Warning
01/02/2018 VIDAS and mini VIDAS. Priority 2 – Warning Warning
01/02/2018 Summary of Field Safety Notice – January 2018 3rd Party Publications
29/01/2018 HPRA Information Notice - Food Intolerance Testing - 2018 Update Advisory
26/01/2018 Medtronic MiniMed Infusion Sets. Priority 1 – For Immediate Action For Immediate Action
24/01/2018 Animas Vibe Insulin Pumps. Priority 3 – Advisory. Advisory
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