Field Safety Notices: 3 to 7 June 2024

List of Field Safety Notices from 3 to 7 June 2024.

Overview

If you receive a field safety notice (FSN) from a manufacturer you must always act on it.

MHRA publishes the following for information only.

If you have a question about a particular FSN contact the manufacturer.

Latest FSNs

View the latest FSNs

View a list of FSNs published since January 2020

View FSNs since November 2014. FSNs before this date are on the National Archives website

Abbott: Afinion 2 

22 May 2024

Model: 1116772, 1116774, 1116777, 1116778, 1116770, 1116771

MHRA reference: 30732416 Customer Letter

MHRA reference: 30732416 Distributor Letter

Abbott: Proclaim

June 2024 FA-Q224-NM-3

Spinal Cord-, electr. stimulation sys.

Model: 3660, 3661, 3662, 3664, 3665, 3667

MHRA reference: 30779031 - 2024/006/006/601/056

Abbott: Infinity

June 2024

Deep Brain electr. stimulation sys.

Model: 6660, 6661, 6662, 6663

MHRA reference: 30767067 - 2024/006/006/601/054

Acutronic: fabian HFO Classic and HFOi Ventilators 

15 April 2024

Neonatal/paediatric pulmonary ventilators

Model: 112001; 113001 

MHRA reference: 30709017 - 2024/005/030/601/050 

Amity: Virusolve+ Wipes / Virusolve+ HLD Wipes

24 October 2023

MHRA reference: 30735127 - 2023/010/025/601/093

Beckman Coulter: AU IgM (Immunoglobulin M )

30 May 2024

Total immunoglobulin

MHRA reference: 30767242 - 2024/006/006/601/069 

Cordis: OPTEASE Retrievable VCF and retrieval Catheter 

18 December 2023

MHRA reference: 30710251 

GVS: Aqualine   

28 May 2024

MHRA reference: 30766959 - 2024/006/006/601/053

LORNE Laboratories: Papenzyme-plus 

03 June 2024

Papain immunohematology reagent IVD

MHRA reference: 30743139 - 2024/006/004/601/031 

Micrel: Rythmic Ultima  

05 June 2024

MHRA reference: 30756005 - 2024/006/005/601/034 

Ypsomed: mylife YpsoPump Orbit micro 2.0 infusion sets 

06 June 2024

Electric infusion pump administration set 

MHRA reference: 30767530 FSN - 2024/006/006/601/078

MHRA reference: 30767530 Letter - 2024/006/006/601/078

Updates to this page

Published 19 June 2024