GovWire

Field Safety Notices: 13 to 17 January 2025

Medicines Healthcare Products Regulatory Agency

January 22
17:21 2025

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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

View a list of FSNs published since January 2020

View FSNs since November 2014. FSNs before this date are on the National Archives website

Baxter: Braun Pro 6000

26 June 2024

Infrared patient thermometer, ear

Model: Refer to FSN

MHRA reference: 34454081 2024/006/026/601/029

Baxter: Control-A-Flo Solution Administration Set with Needle Y-site

14 January 2025

FLOW REGULATOR SET

Model: Refer to FSN

MHRA reference: 34440212 2025/001/014/601/029

Holmusk Europe: Management and Supervision Tool (MaST)

3 December 2024

MHRA reference: 34494598

Illumina: NovaSeq 6000Dx Instrument including DRAGEN Server and Illumina DRAGEN Server for NextSeq 550Dx

16 January 2025

Nucleic acid sequence analyser IVD, NGS

Model: Refer to FSN

MHRA reference: 34465698 2025/001/015/601/035

Kirwan: Disposable Bipolar Pencil 25GA Straight

19 November 2024

Model: Refer to FSN

MHRA reference: 34429079 2024/011/019/601/046

Loewenstein Medical: Elisa 300, Elisa 500, Elisa 600, Elisa 800VIT

7 January 2025

Critical Care Ventilator

Software update

Model: Refer to FSN

MHRA reference: 34440538 BfArM xxxxx/24

Medline: Electrosurgical Electrode - UPDATED FSN

9 January 2025

FSN 24-02

Update to FSN issued in April 2024 MHRA ref 29296734

Additional lot numbers are impacted by this new recall

Model: see Annex 1

MHRA reference: 34402496 2024/004/018/601/041

Medtronic: Percept PC Implantable Neurostimulator (INS) Model B35200 Unable to be Interrogated UPDATED FSN

January 2025

Software Update

Medtronic Reference: FA1231

Model: Refer to FSN

MHRA reference: 34458244 2022/004/001/291/004

Medtronic: Percept PC Model B35200 Implantable Neurostimulator (INS) UPDATED FSN

January 2025

INS Failure After Cardioversion - Software Update

Medtronic Reference: FA1206

Model: Refer to FSN

MHRA reference: 34458194 2021/010/015/579/002

Philips: Azurion and Allura Xper series Follow up FSN

15 November 2024

Interventional Fluoroscopic X-Ray System

Follow up to FSN issued in June 2023 - MHRA ref.5303178

Model: Refer to FSN

MHRA reference: 34417413 2023/006/008/601/030

Philips: Achieva 1.5T, Achieva 1.5T Conversion, Achieva 1.5

1 October 2024

Magnetic Resonance Imaging (MRI) unit

Model: Refer to FSN

MHRA reference: 34453566 2024/004/026/601/037

Philips: Tack Endovascular System

January 2025

Multiple peripheral artery stent, bare metal

Model: Refer to FSN

MHRA reference: 34425077 2025/001/013/601/032

Vygon: LIFECATH PICC+MST DOUBLE 4.5FG B10

10 January 2025

Catheters, Central Venous, Peripherally Inserted

Batch/LOT: 101024GT

MHRA reference: 34424440 2025/001/013/601/053

Zimmer Biomet: Optipac Vacuum mixing system

16 January 2025

Orthopaedic cement, antimicrobial

Model: Refer to FSN Attachment 2 - Affected Product List

MHRA reference: 34467376 2025/001/016/601/099

Updates to this page

Published 21 January 2025
Last updated 22 January 2025 +show all updates
  1. Added 'Holmusk Europe: Management and Supervision Tool (MaST)'.

  2. First published.

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