Field Safety Notices: 24 to 28 March 2025
Source: gov.uk (2025-04-01)

List of Field Safety Notices from 24 to 28 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/rERAzf7G0Ssm8x1h)

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 Molecular, Inc: Alinity m System

19 March 2025

Model: Refer to FSN

MHRA reference: 35154752 (https://mhra-gov.filecamp.com/s/d/3cqfssG9p0a1Cj93) Customer reply form - 2025/003/xx-xxxx-xxxx

MHRA reference: 35154752 (https://mhra-gov.filecamp.com/s/d/lEAKL3Ua9c2m4U0z) FSN

Avanos Medical Inc: Ballard Closed Suction Systems

21 March 2025

Suction System Catheter, General Purpose

Model: 198; 210; 20083; 220135; 2210-5; 2271418-5; 227-5

MHRA reference: 35145199 (https://mhra-gov.filecamp.com/s/d/RPfXgno54UIOAf8E) 2025/003/xx-xxxx-xxxx

B. Braun Avitum AG: Single Needle Cross Over/Single Needle Bloodlines

19 March 2025

for Dialog+ and Dialog iQ dialysis machines

Model: Refer to FSN

MHRA reference: 35135270 (https://mhra-gov.filecamp.com/s/d/IbLgtYgu6fsnI4fg) 2025/003/xx-xxxx-xxxx

Beckman Coulter: DxC 500i Clinical Analyzer

14 March 2025

Ref Number: FSN-25025

Analyzer Module: DxC 500 AU Module w/ISE, DxC 500i / DxC 500 AU Module, DxC 500i

Software version: SW 1.3.0 and 1.3.2

MHRA reference: 35155883 (https://mhra-gov.filecamp.com/s/d/wl7gWuuyRQESbEqU) FSN 2025/003/xx-xxxx-xxxx

MHRA reference: 35155883 (https://mhra-gov.filecamp.com/s/d/WDwYZP6iqEt0zsIX) Vigilance response form

Beckman Coulter: DxC 500i Clinical Analyzer

14 March 2025

Ref Number: FSN-25026

Analyzer Module: Access 2 Module, DxC 500i

Software version: SW v1.3.0 and 1.3.2

MHRA reference: 35155351 (https://mhra-gov.filecamp.com/s/d/cYq86h161mqgbEF1) FSN 2025/003/xx-xxxx-xxxx

MHRA reference: 35155351 (https://mhra-gov.filecamp.com/s/d/pgnCHRDDN4UFDoZ2) Vigilance response form

Corin Limited: Trinity Acetabular Shells

20 March 2025

Ref: FA 2025 003 – FSN Rev: 1.0

Trinity 56mm Taper Size 4 Cluster Shell

Model: 321.04.356

LOT: 568616

MHRA reference: 35133891 (https://mhra-gov.filecamp.com/s/d/cr5YRwyswSVHC8iG) 2025/003/xx-xxxx-xxxx

Covidien llc: Hugo™ Robotic-Assisted Surgery (RAS) Sterile Interface Module (SIM) Intermittent Connectivity

March 2025

Medtronic Reference: FA1473

Model: MRASA0003

MHRA reference: 35154949 (https://mhra-gov.filecamp.com/s/d/ZUVZyZiYXoWqCNMD) 2025/003/xx-xxxx-xxxx

Epocal Inc.: epoc® Blood Analysis System

March 2025

Multi blood gas/haem/electrolyte analyte IVD rgt

Model: Refer to FSN

MHRA reference: 35155552 (https://mhra-gov.filecamp.com/s/d/I4j1B2M551GiIAyA) 2025/003/xx-xxxx-xxxx

Hill-Rom, Inc: Progressa Bed

25.03.2025

FA-2025-006

Basic electric hospital bed

Model: refer to FSN

MHRA reference: 35155002 (https://mhra-gov.filecamp.com/s/d/LFWGW58sea3clgdL) - FSN 2025/003/xx-xxxx-xxxx

MHRA reference: 35155002 (https://mhra-gov.filecamp.com/s/d/ZHTqVo61maaFmyqM) – Customer reply form

Waldemar Link GmbH: LinkSymphoKnee Femoral and Tibial Augments

24.03.2025

FSN Ref.: R-2025-02

Knee arthroplasty wedge

Model: Refer to FSN

MHRA reference: 35145588 (https://mhra-gov.filecamp.com/s/d/IkhVWW0e43RxnG2o) 2025/003/xx-xxxx-xxxx