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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
04/05/2018 Infinity Acute Care System (IACS) and Standalone Infinity M540 patient monitors Software versions VG2.2 to VG4.1. Priority 2 - Warning Warning
04/05/2018 Infinity Acute Care System (IACS) and Standalone Infinity M540 patient monitors Software versions VG2.2 to VG6.0. Priority 2 - Warning Warning
03/05/2018 S-Shaped Urethral (F8-F24) Dilators & Urethral Dilators (F6-F16). Priority 1 – For Immediate Action. For Immediate Action
03/05/2018 Jaundice Meters JM-103, JM-105. Priority 2 – Warning Warning
02/05/2018 BD Vacutainer® EDTA & Lithium Heparin blood collection tubes - IFU update. Priority 2 – Warning Warning
02/05/2018 Summary of Field Safety Notice – April 2018 3rd Party Publications
01/05/2018 BD Posiflush™ Heparin Lock Flush Syringes & BD™ Pre-filled Normal Saline Syringes. Priority 1 – For Immediate Action For Immediate Action
05/04/2018 Summary of Field Safety Notices - March 2018 3rd Party Publications
03/04/2018 T34 Ambulatory Syringe Pumps. Priority 2 – Warning Warning
07/03/2018 Summary of Field Safety Notice – February 2018 3rd Party Publications
07/02/2018 Head Lice Treatment Products – Risk of Fire. Priority 2 – Warning Warning
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
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