Field Safety Notices: 19 to 23 May 2025
List of Field Safety Notices from 19 to 23 May 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
Bard Access Systems: Refer to FSN
15th May 2025
Peripherally-inserted central venous catheter
MHRA reference: 35612425 2024/010/028/601/056
MHRA reference: 35612425 2024/010/028/601/056 – Attachment 1
BD Switzerland Sàrl : Refer to FSN
13th May 2025
See comments
MHRA reference: 35659729
Beckman Coulter: DxI 9000 Access Immunoassay Analyzer
13th May 2025
See Section 8
MHRA reference: 35636707 2025/005/019/601/065
CareDx Pty Ltd : AlloSeq cfDNA
22nd May 2025
MHRA reference: 35672441 2025/005/022/601/053
Change Healthcare: CHC Hemodynamics
23rd May 2025
Cardiac Catheterization laboratory computer
Model: 15.0.1,15.1.1
MHRA reference: 35649227 2025/005/020/601/120
Covidien llc : Newport HT and HT70™ Plus Ventilators
May 2025
Neonatal/adult intensive-care ventilator
Model: HT70PM-WW-NA, HT70PM-SY-EU, HT70PM-SY-NA, HT70PM-SY-UK, HT70PM-ES-EU, HT70PM-ES-NA, HT70PM-JP-NA, HT70PM-PT-BR HT70PM-WW-EU HT70M-JP-NA, HT70M-CN-NA, HT70M-ES-EU, HT70M-PT-BR, HT70M-SY-EU, HT70M-WW-EU, HT70M-WW-NA, HT70-SY-EU, HT70PM-SY-AS, DLHT70PM-WW-NA, HT70PM-WW-EU, HT70PM-WW-UK
MHRA reference: 35658497 2025/005/021/601/034
MHRA reference: 35658497 2025/005/021/601/034 – Attachment A
MHRA reference: 35658497 2025/005/021/601/034 – Attachment B
Covidien llc: Microstream Advance and Luer Sampling Lines
May 2025
Class I: R9099, Class IIa: R03010204, R9099
MHRA reference: 35651933 2025/002/019/601/080
Drägerwerk AG : SafeStar Plus, TwinStar HEPA Plus
May 2025
Filter, Ventilator
Model: multiple (refer to FSN)
MHRA reference: 35649623 2025/005/020/601/072
Exmoor Plastics: Exmoor Suction Clearance Kits
20th May 2025
Secretion Suction Kit
Model: SC6 SC4JH
MHRA reference: 35659311 2025/005/021/601/009
GE Healthcare Finland Oy : Centricity High Acuity Anesthesia / Critical Care
FMI 38017
Patient health record information system
MHRA reference: 35637011 2025/005/019/601/012
Maco Pharma : Whole Blood Collection Sets
21st May 2025
Model: LQT614B, FQE614B, NPT610A, LQT6287LU
MHRA reference: 35657996 2025/005/020/601/027
Maco Pharma: LQT, NPT, NQT
22nd May 2025
In-Line Red Cell Filtration System
Model: LQT710X, NPT610A, NQT614B, LQT613U
MHRA reference: 35671319 2025/005/021/601/023
Quantum Surgical: EPIONE device
16th May 2025
Robotic surgical navigation system
Model: 30-0001
MHRA reference: 35608489 2025/005/016/601/025
RaySearch Laboratories: RayStation
13th May 2025
Various Radiotherapy Instruments - Software
Model: 2024B
MHRA reference: 35613828 2025/005/016/601/050