Field Safety Notices: 3 to 7 February 2025
Source: gov.uk (2025-02-12)

List of Field Safety Notices from 3 to 7 February 2025.

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/bva87z7CkbwJf5KU)

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)

Allurion: Allurion Device / Elipse Gastric Balloon System

22 January 2025

Balloon, gastric, appetite-suppressing

Model: 10D

MHRA reference: 34605771 (https://mhra-gov.filecamp.com/s/d/DbaikuoZ1cqMsBo9) 2025/001/xx-xxxx-xxxx

Baxter : EXTENDED LIFE PD TRANSFER SET, MINICAP EXTEND LIFE

23 October 2024

Tubing set, peritoneal dialysis

MHRA reference: 34640703 (https://mhra-gov.filecamp.com/s/d/6LVdxDqLKOFm8Duj) 2024/010/xx-xxxx-xxxx - Letter

MHRA reference: 34640703 (https://mhra-gov.filecamp.com/s/d/s5KYKgZ9XR3C9uyu) 2024/010/xx-xxxx-xxxx – Updated FSN

Baxter: AK 95, AK 96, AK 98

28 January 2025

Haemodialysis system Institutional / Home-Use

Model: 107012, 107119, 110656, 114742, 115250, 955404, 955604

MHRA reference: 34599078 (https://mhra-gov.filecamp.com/s/d/aQHPdnh12wlR053D) 2025/001/xx-xxxx-xxxx

MHRA reference: 34599078 (https://mhra-gov.filecamp.com/s/d/ZldEnWdxLbxrYDw5) 2025/001/xx-xxxx-xxxx - Home Patient Letter

MHRA reference: 34599078 (https://mhra-gov.filecamp.com/s/d/r5G44l1WjDfle6YE) 2025/001/xx-xxxx-xxxx – Attachment 1

BRAINLAB: Multidisciplinary medical image management SW

CAPA-20250117-002791

Origin Data Management

Model: 30074-04B, 30074-04C

MHRA reference: 34641428 (https://mhra-gov.filecamp.com/s/d/1QIGmIJEy9aJGmTH) 2025/002/005/601/017

Dexcom: Dexcom G6 Receiver

January/February 2025

Percutaneous glucose monitoring system

Model: MT24078-1 (mg/dL), MT24078-2 (mmol/L)

MHRA reference: 34652451 (https://mhra-gov.filecamp.com/s/d/ODah372NDJFbSYca) 2025/001/009/601/082

Drager: Ventstar Flex breathing circuits

February 2025

MHRA reference: 34630476 (https://mhra-gov.filecamp.com/s/d/pZZiwr7KG3thG6oy) 2025/002/004/601/068

Gama Healthcare: Clinell Contiplan

23 January 2025

MHRA reference: 34613318 (https://mhra-gov.filecamp.com/s/d/2T8p4uqCmmlMf2SU) 2025/001/xx-xxxx-xxxx

Hamilton Medical: In2Flow Nasal cannula (sizes S, M, L)

6 February 2025

Nasal oxygen cannula, basic

Model: 10076606, 10076605, 10076604

MHRA reference: 34649940 (https://mhra-gov.filecamp.com/s/d/Jvse5Z849lAYPauh) 2025/002/006/601/042

MHRA reference: 34649940 (https://mhra-gov.filecamp.com/s/d/9IYONp8PPYVMj0rj) 2025/002/006/601/042

Hologic: Panther Fusion Tube Trays

30 January 2025

Model: FAB-15004

MHRA reference: 34601187 (https://mhra-gov.filecamp.com/s/d/boNYByZP9pQiekJl) 2025/001/xx-xxxx-xxxx

KLS Martin: OR light system (marLED E marLED X)

9 December 2024

Op./ex./treatm light mount,fix

MHRA reference: 34603880 (https://mhra-gov.filecamp.com/s/d/ClD3uA0U24W1Gxoo) 2024/012/010/601/022

Medtronic: 37307: Activa™ SC 48054: Pocket Adaptor

January 2025

MHRA reference: 34613389 (https://mhra-gov.filecamp.com/s/d/BV7m28BZT1A5ZtUD) 2024/xx-xxxx-xxxx

Steris: Cataract Set and Zeiss Microscope Caps

24 January 2025

MHRA reference: 34606148 (https://mhra-gov.filecamp.com/s/d/5UDr9mpDDbiUZuJ1) 2024/012/xx-xxxx-xxxx