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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:

Field safety notices (FSNs), published by manufacturers.
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.

Order by:

Show:

Date	Title	Type
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
05/03/2013	Use of Luer adaptors with Needle-Free Connection Systems and prefilled Syringes	Advisory
18/12/2012	IMB re-issues leaflet on Automated External Defibrillators (AEDs)	Advisory
17/12/2012	Defibtech DDU-100 series AED marketed under the brand names Lifeline AED, ReviveR AED and Lifeforce AED	Advisory
17/12/2012	Samaritan PAD 300/PAD 300P Automated External Defibrillators	Advisory
08/10/2012	WISPA PORTABLE HOIST AND ATTACHMENT HANDLE	Advisory
10/09/2012	HeartStart MRx	Advisory
06/09/2012	ArjoHuntleigh Passive Patient Lifts and Ceiling Lifts with four-point hanger bars intended for use with Passive Clip Slings and Clip Flite Slings	Advisory
28/08/2012	Animas Insulin Pump (IR 1200, 2020, One Touch Ping, Vibe)	Advisory
24/08/2012	EMS Medical Neonatal & Paediatric Endotracheal Tube Clamp / Holder	Advisory