Field Safety Notices: 12 to 16 May 2025
Source: gov.uk (2025-05-20)

List of Field Safety Notices from 12 to 16 May 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/wNFtjHqeDCwLs5ZR)

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)

Cook Incorporated: Cook Beacon® Tip 5.0 Fr Angiographic Catheter

13 May 2025

FSN & FSCA Ref: 2025FA0003

Angiographic catheter, single-use

Model: Refer to Attachment 1 – Product Information Table

MHRA reference: 35554112 (https://mhra-gov.filecamp.com/s/d/jmXNIa5677qsAHfA) Attachment 1 – Product Information Table

MHRA reference: 35554112 (https://mhra-gov.filecamp.com/s/d/pjSO88f5jgUfSGOt) Customer reply form

MHRA reference: 35554112 (https://mhra-gov.filecamp.com/s/d/VMd8yPVn9SHmQYSH) FSN 2025/xx-xxxx-xxxx

Copan Italia S.p.A.: BD BBL™ CultureSwab™ EZ Collection & Transport System

2 May 2025

FSN Ref: FSN-2025-0001

Model: 220144

MHRA reference: 35565678 (https://mhra-gov.filecamp.com/s/d/VuM22TBSl9W6ekQB) Appendix 1 - 2025/xx-xxxx-xxxx

MHRA reference: 35565678 (https://mhra-gov.filecamp.com/s/d/eKIodkcrXq0ODKBN) FSN

GE Healthcare: MUSE 5 systems

GE HealthCare Ref. # 30116

Cardiology information system application software

Model: Refer to FSN

MHRA reference: 35541456 (https://mhra-gov.filecamp.com/s/d/pEkiaXdorkyiEnvJ) 2025/005/009/601/087

Löwenstein Medical SE: Leoni plus transport

8 May 2025

FSCA2025015

Baby Ventilator

Model: Refer to FSN

MHRA reference: 35543098 (https://mhra-gov.filecamp.com/s/d/eMmosSlS8sbnWGGc) 2025/005/009/601/027

Medtronic, Inc: Non-Implanted Medtronic Azure™ S DR Implantable Pulse Generators (IPGs)

April 2025

Medtronic Reference: FA1490

Model: W3DR01, GTIN 00763000956004

Serial Number: RNJ108800G, RNJ108808G, RNJ108810G

MHRA reference: 35531854 (https://mhra-gov.filecamp.com/s/d/uCU6LY52qL8khIpE) Customer Contact Record

MHRA reference: 35531854 (https://mhra-gov.filecamp.com/s/d/ROxQkyQctCzdnr35) FSN - 2025/004/007/601/088

NHSBT Reagents: Copper Sulphate Solution for Blood Donor Haemoglobin Screening

13 May 2025

FSN Ref: QI44365

HAEMOGLOBIN (HB)

Model: Refer to FSN

MHRA reference: 35565448 (https://mhra-gov.filecamp.com/s/d/aCAy4fhlg6SFXMgo) 2025/005/009/601/063

Peter Brehm GmbH: Impactor, iliac peg - MRS-TITAN Maximum

19 May 2025

FSCA-20250502

Prosthesis implantation instrument, orthopaedic

Model: Refer to FSN

MHRA reference: 35599227 (https://mhra-gov.filecamp.com/s/d/kUAyFHx1s3bT34ZC) 2025/xx-xxxx-xxxx

Rocamed France: Endoflow II - Irrigation and Warming System

FSN Ref: FSN Endoflow CP22

‘Instruction for use’ reinforcement

Model: Refer to FSN

MHRA reference: 35595209 (https://mhra-gov.filecamp.com/s/d/9cdhUdLVwAY4EOIT) 2025/xx-xxxx-xxxx

SHAOXING YIBON MEDICAL CO., LTD.: Cup

10 April 2025

Rev 1: September 2018

Medical container or receiver, for washing or holding liquid, instruments, dressings..

Model: Refer to FSN

MHRA reference: 35558903 (https://mhra-gov.filecamp.com/s/d/C3A3QJln0pyP3qrL) 2025/002/xx-xxxx-xxxx