Field Safety Notices: 28 October to 1 November 2024
List of Field Safety Notices from 28 October to 1 November 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 a list of FSNs published since January 2020
View FSNs since November 2014. FSNs before this date are on the National Archives website
Abiomed: Impella heart pump
2 April 2024
Intracardiac Circulatory Assist Axial Pump Cath.
Model: all models of Impella heart pumps
MHRA reference: 33776034 2024/002/025/601/001
Arjo: IndiGo Intuitive Drive Assistance
September 2024
Accessory for basic electric hospital beds
Model: INDI-XXX
MHRA reference: 33615874 2023/012/013/601/033
Becton, Dickinson and Company: See comments box
6 November 2024
See comments box
MHRA reference: 33783989 2024/010/031/601/058
Bordier Affinity Products: As described in the FSN-240829UK – Attached
29 August 2024
MHRA reference: 33744394 2024/010/028/601/045
Dutch Ophthalmic Research Center (DORC): Silicone Oil
September 2024
Vitreous humour replacement medium, intraoperative
MHRA reference: 33772908 2024/010/015/601/033
Getinge: Universal Remote Control
21 October 2024
Medical device remote control keypad
Model: 100925A0
MHRA reference: 33723020 2024/010/025/601/079 - Customer letter
MHRA reference: 33723020 2024/010/025/601/079 - Reply form
HYALTECH: Visthesia 1.5%
10 October 2024
Ophthalmic Viscosurgical Devices
MHRA reference: 33728193 2024/010/024/601/003
SIEMENS Healthineers: Atellica CH β2-Microglobulin (B2M)
October 2024
See section 8
MHRA reference: 33768573 2024/010/029/601/126
Smiths Medical: Tracheal Tube Reusable Introducer and Guides
4 November 2024
Endotracheal tube introducer/guide, reusable
Model: See FSN
MHRA reference: 33768404 2024/010/030/601/028
TAEWOONG Medical : Niti-S Tracheobronchial Uncovered Stent
14 March 2024
Bare-metal tracheal/bronchial stent, sterile
Model: BRxxxxW
MHRA reference: 33728108 2024/003/014/601/001