Field Safety Notices: 24 to 28 March 2025
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 a list of FSNs published since January 2020
View FSNs since November 2014. FSNs before this date are on the National Archives website
Abbott Molecular, Inc: Alinity m System
19 March 2025
Model: Refer to FSN
MHRA reference: 35154752 Customer reply form - 2025/003/025/601/022
MHRA reference: 35154752 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 2025/003/024/601/057
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 2025/003/020/601/049
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 FSN 2025/003/025/601/037
MHRA reference: 35155883 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 FSN 2025/003/025/601/109
MHRA reference: 35155351 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 2025/003/020/601/095
Covidien llc: Hugo™ Robotic-Assisted Surgery (RAS) Sterile Interface Module (SIM) Intermittent Connectivity
March 2025
Medtronic Reference: FA1473
Model: MRASA0003
MHRA reference: 35154949 2025/003/025/601/098
Epocal Inc.: epoc® Blood Analysis System
March 2025
Multi blood gas/haem/electrolyte analyte IVD rgt
Model: Refer to FSN
MHRA reference: 35155552 2025/003/025/601/014
Hill-Rom, Inc: Progressa Bed
25.03.2025
FA-2025-006
Basic electric hospital bed
Model: refer to FSN
MHRA reference: 35155002 - FSN 2025/003/025/601/136
MHRA reference: 35155002 – 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 2025/003/024/601/061