Field Safety Notices: 28 October to 1 November 2024
Source: gov.uk (2025-05-08)

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 the latest FSNs (https://mhra-gov.filecamp.com/s/o/dlr3zCASmSOXxjBZ)

View a list of FSNs published since January 2020 (https://mhra-gov.filecamp.com/s/9g5cLjjFatXruS5U/d)

View FSNs since November 2014 (https://mhra-gov.filecamp.com/s/ZOxdOzRzP22RziUW/fo). FSNs before this date are on the National Archives website (https://webarchive.nationalarchives.gov.uk/*/http:/www.mhra.gov.uk/index.htm)

Abiomed: Impella heart pump

2 April 2024

Intracardiac Circulatory Assist Axial Pump Cath.

Model: all models of Impella heart pumps

MHRA reference: 33776034 (https://mhra-gov.filecamp.com/s/d/HH50N8MoV5DdrKPf) 2024/002/xx-xxxx-xxxx

Arjo: IndiGo Intuitive Drive Assistance

September 2024

Accessory for basic electric hospital beds

Model: INDI-XXX

MHRA reference: 33615874 (https://mhra-gov.filecamp.com/s/d/8zDxJJMuY4RcV0tl) 2023/012/013/601/033

Becton, Dickinson and Company: See comments box

6 November 2024

See comments box

MHRA reference: 33783989 (https://mhra-gov.filecamp.com/s/d/hBhwm81W4uMp1hiX) 2024/010/xx-xxxx-xxxx

Bordier Affinity Products: As described in the FSN-240829UK – Attached

29 August 2024

MHRA reference: 33744394 (https://mhra-gov.filecamp.com/s/d/J2JTePJ9w7WPXIFt) 2024/010/xx-xxxx-xxxx

Cartiva Inc (Stryker): Cartiva Synthetic Cartilage Implant (SCI) 6mm, 8mm

31 October 2024

MHRA reference: 35515343 (https://mhra-gov.filecamp.com/s/d/aQnhSWIuY35B2hrv) 2024/011/015/601/048

Dutch Ophthalmic Research Center (DORC): Silicone Oil

September 2024

Vitreous humour replacement medium, intraoperative

MHRA reference: 33772908 (https://mhra-gov.filecamp.com/s/d/3VEy87XQNuJl6X5t) 2024/010/015/601/033

Getinge: Universal Remote Control

21 October 2024

Medical device remote control keypad

Model: 100925A0

MHRA reference: 33723020 (https://mhra-gov.filecamp.com/s/d/TysV9S8pWXplnNGo) 2024/010/xx-xxxx-xxxx - Customer letter

MHRA reference: 33723020 (https://mhra-gov.filecamp.com/s/d/yPKD2sAz1jMwFRhZ) 2024/010/xx-xxxx-xxxx - Reply form

HYALTECH: Visthesia 1.5%

10 October 2024

Ophthalmic Viscosurgical Devices

MHRA reference: 33728193 (https://mhra-gov.filecamp.com/s/d/FVoI2Q1X36ste4pi) 2024/010/xx-xxxx-xxxx

SIEMENS Healthineers: Atellica CH β2-Microglobulin (B2M)

October 2024

See section 8

MHRA reference: 33768573 (https://mhra-gov.filecamp.com/s/d/cTAmgXzwQg13NGjU) 2024/010/xx-xxxx-xxxx

Smiths Medical: Tracheal Tube Reusable Introducer and Guides

4 November 2024

Endotracheal tube introducer/guide, reusable

Model: See FSN

MHRA reference: 33768404 (https://mhra-gov.filecamp.com/s/d/73coha7rTpO5QI7U) 2024/010/xx-xxxx-xxxx

TAEWOONG Medical : Niti-S Tracheobronchial Uncovered Stent

14 March 2024

Bare-metal tracheal/bronchial stent, sterile

Model: BRxxxxW

MHRA reference: 33728108 (https://mhra-gov.filecamp.com/s/d/If4iw9ZY6E5bFxPc) 2024/003/014/601/001