Field Safety Notices: 17 to 21 February 2025
Source: gov.uk (2025-02-25)

List of Field Safety Notices from 17 to 21 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/1Ljz5ulRPgPds8ZN)

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)

Abbott: Assurity, Endurity

February 2025

Dual -chamber impl. pm

Model: PM1140, PM1152, PM1160, PM1162, PM1172, PM1272, PM2140, PM 2152, PM2162, PM2172, PM2240, PM2272

MHRA reference: 34767642 (https://mhra-gov.filecamp.com/s/d/iULzk4uvRCxUDnMO) 2025/002/014/601/040

Baxter: Welch Allyn non-automated blood pressure gauges

19th February 2025

Model: See Attachment A

MHRA reference: 34773300 (https://mhra-gov.filecamp.com/s/d/3Tf7hOKuvHeadN4I)

BD: BD PCR Cartridge

15th January 2025

See comments

Model: < Add model (normal style)>

MHRA reference: 34747586 (https://mhra-gov.filecamp.com/s/d/AUMzPKk1vukh6bHD) 2024/012/013/601/040

Beckman Coulter: DxI 9000 Access Immunoassay Analyzer

7th February 2025

See Section 8

MHRA reference: 34764500 (https://mhra-gov.filecamp.com/s/d/XYZwMOjtIGvB0OWq) 2025/002/018/601/065

Beckman Coulter: DxI 9000 Access Immunoassay Analyzer

7th February 2025

Chemiluminescent Immunoassay

Model: < Add model (normal style)>

MHRA reference: 34787668 (https://mhra-gov.filecamp.com/s/d/RShzLzwLK2LE5B47) 2025/002/019/601/140

Cook Medical: Hemospray Endoscopic Hemostat

12th February 2025

Non-organic haemostatic agent, sterile

MHRA reference: 34776985 (https://mhra-gov.filecamp.com/s/d/t0rZk0heHSCqEjba) 2024/010/xx-xxxx-xxxx - Updated FSN dated February 2025, additional lot numbers affected.

MHRA reference: 34776985 (https://mhra-gov.filecamp.com/s/d/yTZlVZij5V4M9dpl) 2024/010/xx-xxxx-xxxx - New lot numbers (3) are highlighted in yellow in the list of affected lot numbers.

GCE: GCE Combi valve

22nd July 2022

MHRA reference: 34786931 (https://mhra-gov.filecamp.com/s/d/YIg5yZRkWWGXBRFI) 2025/002/013/601/070

Human Care: Altair Lifting Solutions

26th November 2025

Overhead track patient lifting/transfer system

MHRA reference: 34783023 (https://mhra-gov.filecamp.com/s/d/j5e9dUNOJoKfaYSk) 2025/002/018/601/033

Medtronic: Microstream Advance and Luer Sampling Lines

FA1432

Class I: R9099, Class IIa: R03010204, R9099

Model: < Add model (normal style)>

MHRA reference: 34774533 (https://mhra-gov.filecamp.com/s/d/1V6JEyxbMC4BC8WZ) 2025/002/019/601/080

Siemens Healthineers: Atellica CH Diluent

February 2025

Buffered sample diluent IVD

Model: N/A

MHRA reference: 34747627 (https://mhra-gov.filecamp.com/s/d/3ngwjMZCKFlKsjph) 2025/002/017/601/033

MHRA reference: 34747627 (https://mhra-gov.filecamp.com/s/d/gHSCdZQrADcEXs7p) 2025/002/017/601/033 – Customer letter

Smiths Medical: Intubation ORAL/NASAL Endotracheal Tube

19th February 2025

Basic endotracheal tube, single-use

Model: See FSN

MHRA reference: 34737817 (https://mhra-gov.filecamp.com/s/d/2HWNMDn0ZNQFZNlr) 2025/002/014/601/038