Field Safety Notices: 3 to 7 February 2025
List of Field Safety Notices from 3 to 7 February 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
Allurion: Allurion Device / Elipse Gastric Balloon System
22nd January 2025
Balloon, gastric, appetite-suppressing
Model: 10D
MHRA reference: 34605771 2025/001/031/601/011
Baxter : EXTENDED LIFE PD TRANSFER SET, MINICAP EXTEND LIFE
23rd October 2024
Tubing set, peritoneal dialysis
Model: < Add model (normal style)>
MHRA reference: 34640703 2024/010/022/601/043 - Letter
Baxter: AK 95, AK 96, AK 98
28th January 2025
Haemodialysis system Institutional / Home-Use
Model: 107012, 107119, 110656, 114742, 115250, 955404, 955604
MHRA reference: 34599078 2025/001/028/601/056
MHRA reference: 34599078 2025/001/028/601/056 - Home Patient Letter
MHRA reference: 34599078 2025/001/028/601/056 – Attachment 1
BRAINLAB: Multidisciplinary medical image management SW
CAPA-20250117-002791
Origin Data Management
Model: 30074-04B, 30074-04C
MHRA reference: 34641428 2025/002/005/601/017
Chromsystems: MassTox Antimycotic Drugs/EXTENDED Cali/Con
03 February 2025
Multiple antifungal therapeutic drug monitoring
Model: 92051/XT, 0253/XT, 0254/XT
MHRA reference: 38212800 2025/002/004/601/047
Dexcom: Dexcom G6 Receiver
January/February 2025
Percutaneous glucose monitoring system
Model: MT24078-1 (mg/dL), MT24078-2 (mmol/L)
MHRA reference: 34652451 2025/001/009/601/082
Drager: Ventstar Flex breathing circuits
February 2025
MHRA reference: 34630476 2025/002/004/601/068
Gama Healthcare: Clinell Contiplan
23rd January 2025
MHRA reference: 34613318 2025/001/023/601/049
Hamilton Medical: In2Flow Nasal cannula (sizes S, M, L)
06 February 2025
Nasal oxygen cannula, basic
Model: 10076606, 10076605, 10076604
MHRA reference: 34649940 2025/002/006/601/042
MHRA reference: 34649940 2025/002/006/601/042
Hologic: Panther Fusion Tube Trays
30th January 2025
Model: FAB-15004
MHRA reference: 34601187 2025/001/031/601/061
KLS Martin: OR light system (marLED E marLED X)
9th December 2024
Op./ex./treatm light mount,fix
Model: < Add model (normal style)>
MHRA reference: 34603880 2024/012/010/601/022
Medtronic: 37307: Activa™ SC 48054: Pocket Adaptor
January 2025
MHRA reference: 34613389 2024/005/014/601/019
Ortho Clinical Diagnostics: ORTHO Optix Reader BioVue
February 2025
Agglutination assay digital imaging analyzer IVD
MHRA reference: 38235287 2025/002/007/601/048
Steris: Cataract Set and Zeiss Microscope Caps
24th January 2025
MHRA reference: 34606148 2024/012/031/601/075