Field Safety Notices: 10 to 14 March 2025
Source: gov.uk (2025-03-19)

List of Field Safety Notices from 10 to 14 March 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/kbiD3OaxQ0gbERGk)

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)

Baxter Medical: TruSystem 7500 surgical table systems

12 March 2025

Field Action Reference: FA-2025-004

Universal operating table, electromechanical

Model: Refer to FSN

MHRA reference: 34981921 (https://mhra-gov.filecamp.com/s/d/sK8SYzcGW2FWYbda) 2025/003/012/601/013

BD: 4Fr Single-Lumen PowerPICC Catheters - UPDATED FSN

11 March 2025

REF: MDS-24-5154-B

UPDATE to FSN dated 30th October 2024 - 33739247 (https://mhra-gov.filecamp.com/s/d/Xq1NiJkskxYldQ10)

Peripherally-inserted central venous catheter (SOLO and non-SOLO versions)

Type of Action: Product Removal

Model: Refer to Appendix 1 of FSN

MHRA reference: 34964943 (https://mhra-gov.filecamp.com/s/d/2pRCwbybgkG6tpUT) 2024/010/xx-xxxx-xxxx

Beckman Coulter: Inhibin B Gen II Reagent

21 February 2025

REF: A81303

LOT/BN: Refer to FSN

MHRA reference: 34945477 (https://mhra-gov.filecamp.com/s/d/jU9SZTBB75BcE7Li) 2025/003/007/601/062 - Customer response form

MHRA reference: 34945477 (https://mhra-gov.filecamp.com/s/d/RCWXcC8G1mmYBv1q) 2025/003/007/601/062 - FSN

Beckman Coulter: IRMA IGF-I

21 February 2025

REF: A15729

INDIVIDUAL AND SPECIFIED HORMONES / PROTEINS

LOT/BN: Refer to FSN

MHRA reference: 34944552 (https://mhra-gov.filecamp.com/s/d/f43XAWUhplatqxoH) 2025/003/007/601/069 – Customer response form

MHRA reference: 34944552 (https://mhra-gov.filecamp.com/s/d/zBtnVsJC8fLYdL2S) 2025/003/007/601/069 – FSN

Biosense Webster: VARIPULSE Bi-Directional Ablation Catheters

17.02.2025

Cardiac irreversible electroporation system catheter

Model: Refer to FSN

MHRA reference: 34992802 (https://mhra-gov.filecamp.com/s/d/B2JcrweaSOeHWHfP) 2025/002/017/601/049

DiaMed GmbH: Multiple products, see list below

13.03.2025

Bio-Rad Reference: FSCA 002-25

Model: Refer to “FSCA 002-25 product list_01”

MHRA reference: 34992253 (https://mhra-gov.filecamp.com/s/d/sm8OW7N1iQA4rMDk) 2025/003/013/601/105

GE HealthCare: MIM Software

GE HealthCare Ref. # 21001

PACS, software

Model: versions 7.2.0 through 7.2.6

MHRA reference: 34971272 (https://mhra-gov.filecamp.com/s/d/ASY5KtymYB6ukpgT) 2025/003/011/601/084

Limacorporate S.p.A: Guide for Locking Caps Insertion – Different sizes

10 March 2025

FSCA number: 20250001

Model: Refer to FSN

MHRA reference: 34971207 (https://mhra-gov.filecamp.com/s/d/PJqzAADMK7CkJVdD) 2025/003/011/601/060

Medtronic: MiniMed™ Paradigm™, MiniMed™ 600 series, and MiniMed™ 700 series insulin pump system

February 2025

Medtronic reference: FA1446

Model: Refer to FSN

MHRA reference: 34951064 (https://mhra-gov.filecamp.com/s/d/klkClxS2JfvU1jZV) – Diabetes Community letter

MHRA reference: 34951064 (https://mhra-gov.filecamp.com/s/d/ofQyHvQjJEJhyndc) – Healthcare professional letter

Medtronic: NIM Vital™ Nerve Monitoring System Stimulus Artifact

March 2025

Medtronic Reference: FA1482

Nerve-locating system

Model: Refer to FSN

MHRA reference: 34971386 (https://mhra-gov.filecamp.com/s/d/syA5OVNSbS2yjcWL) 2025/003/011/601/024 – Customer ack form

MHRA reference: 34971386 (https://mhra-gov.filecamp.com/s/d/fvv74zyTTpHu1Fyh) 2025/003/011/601/024 – FSN

Philips: Philips DXR System

07 March 2025

DuraDiagnost, DuraDiagnost Compact

Model: Refer to FSN

MHRA reference: 34981628 (https://mhra-gov.filecamp.com/s/d/uAInF4HLnRNWUsah) 2025/003/011/601/019

Straumann Ltd: TLX/TLX Guided Implant Driver xx-xxxx-xxxx

xx-xxxx-xxxx

FSN Ref: ER25-0064

Dental implant holding endpiece, reusable

LOT: GLKJ9 and LGMZ8

MHRA reference: 34945418 (https://mhra-gov.filecamp.com/s/d/P6RliWun5XSsZGOE) 2025/003/006/601/065

Vygon UK Ltd: LIFECATH BIFLUX DOUBLE LUMEN CATHETER

04 March 2025

FSN – Identifier: 2503/51349/00

Product code: 00229370

Model: Refer to FSN

MHRA reference: 34959188 (https://mhra-gov.filecamp.com/s/d/nYygYEPoX9PAC6f7) 2025/003/010/601/077

Zimmer Biomet: Comprehensive® Shoulder Primary Stem (5 mm Micro, 6 mm Micro, 7 mm Micro & 7 mm Mini)

13 March 2025

Comprehensive Shoulder System

Model: Refer to FSN

MHRA reference: 34992148 (https://mhra-gov.filecamp.com/s/d/nazdDy2G8Nyvcc3G) 2025/003/013/601/057