Field Safety Notices: 19 to 23 May 2025
Source: gov.uk (2025-06-06)

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 the latest FSNs (https://mhra-gov.filecamp.com/s/o/VzsC4KiypBcpnf3W)

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)

Bard Access Systems: Refer to FSN

15th May 2025

Peripherally-inserted central venous catheter

MHRA reference: 35612425 (https://mhra-gov.filecamp.com/s/d/NMsT8YJUxihq3BU9) 2024/010/xx-xxxx-xxxx

MHRA reference: 35612425 (https://mhra-gov.filecamp.com/s/d/sefmAg59g923RqA0) 2024/010/xx-xxxx-xxxx – Attachment 1

BD Switzerland Sàrl : Refer to FSN

13th May 2025

See comments

MHRA reference: 35659729 (https://mhra-gov.filecamp.com/s/d/H17q6Mn6SVF6oQ8c)

Beckman Coulter: DxI 9000 Access Immunoassay Analyzer

13th May 2025

See Section 8

MHRA reference: 35636707 (https://mhra-gov.filecamp.com/s/d/LGpGzKVrT9wQDeZD) 2025/005/019/601/065

MHRA reference: 35636707 (https://mhra-gov.filecamp.com/s/d/ob66e64xS9MnpuFI) 2025/005/019/601/065 - Vigilance Response Form

MHRA reference: 35636707 (https://mhra-gov.filecamp.com/s/d/IVhh7inpGCepbZvP) 2025/005/019/601/065 - Customer Letter UK

CareDx Pty Ltd : AlloSeq cfDNA

22nd May 2025

MHRA reference: 35672441 (https://mhra-gov.filecamp.com/s/d/RFLT7ywxB0ut4wcm) 2025/005/xx-xxxx-xxxx

Change Healthcare: CHC Hemodynamics

23rd May 2025

Cardiac Catheterization laboratory computer

Model: 15.0.1,15.1.1

MHRA reference: 35649227 (https://mhra-gov.filecamp.com/s/d/A4ah6rSwfNXMXZd0) 2025/005/xx-xxxx-xxxx

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 (https://mhra-gov.filecamp.com/s/d/OMj4445AbK28dD9O) 2025/005/xx-xxxx-xxxx

MHRA reference: 35658497 (https://mhra-gov.filecamp.com/s/d/05kulcVroz3hQ1Cl) 2025/005/xx-xxxx-xxxx – Attachment A

MHRA reference: 35658497 (https://mhra-gov.filecamp.com/s/d/C4tPgl8sxdQ3MJuv) 2025/005/xx-xxxx-xxxx – Attachment B

Covidien llc: Microstream Advance and Luer Sampling Lines

May 2025

Class I: R9099, Class IIa: R03010204, R9099

MHRA reference: 35651933 (https://mhra-gov.filecamp.com/s/d/zYCeWUVRWbHniONQ) 2025/002/019/601/080

Drägerwerk AG : SafeStar Plus, TwinStar HEPA Plus

May 2025

Filter, Ventilator

Model: multiple (refer to FSN)

MHRA reference: 35649623 (https://mhra-gov.filecamp.com/s/d/OxSuzLH82nhhqmNe) 2025/005/xx-xxxx-xxxx

Exmoor Plastics: Exmoor Suction Clearance Kits

20th May 2025

Secretion Suction Kit

Model: SC6 SC4JH

MHRA reference: 35659311 (https://mhra-gov.filecamp.com/s/d/JYbOMi7nNQJAPhwp) 2025/005/xx-xxxx-xxxx

GE Healthcare Finland Oy : Centricity High Acuity Anesthesia / Critical Care

FMI 38017

Patient health record information system

MHRA reference: 35637011 (https://mhra-gov.filecamp.com/s/d/I46APZNOktGa83FE) 2025/005/019/601/012

Intervascular SAS: HEMAPATCH WOVEN

20 May 2025

Field Safety Notice – RC044

Graft, vascular, synthetic

Model: HEW100/100P (1); HEW25/100P (1) ; HEW25/50P (1) ; HEW50/50P (1) ; HEW75/75P (1)

MHRA reference: 35829014 (https://mhra-gov.filecamp.com/s/d/Ex5t944bGeaz3IXK) - Customer response form

MHRA reference: 35829014 (https://mhra-gov.filecamp.com/s/d/eZs1KXkhLZp6FyRk) - FSN

Maco Pharma : Whole Blood Collection Sets

21st May 2025

Model: LQT614B, FQE614B, NPT610A, LQT6287LU

MHRA reference: 35657996 (https://mhra-gov.filecamp.com/s/d/5SpggGpUo7Sudfo6) 2025/005/xx-xxxx-xxxx

Maco Pharma: LQT, NPT, NQT

22nd May 2025

In-Line Red Cell Filtration System

Model: LQT710X, NPT610A, NQT614B, LQT613U

MHRA reference: 35671319 (https://mhra-gov.filecamp.com/s/d/a6COc5L6dVJMvhRv) 2025/005/xx-xxxx-xxxx

Quantum Surgical: EPIONE device

16th May 2025

Robotic surgical navigation system

Model: 30-0001

MHRA reference: 35608489 (https://mhra-gov.filecamp.com/s/d/iyAFe4RGChuCmg2r) 2025/xx-xxxx-xxxx

RaySearch Laboratories: RayStation

13th May 2025

Various Radiotherapy Instruments - Software

Model: 2024B

MHRA reference: 35613828 (https://mhra-gov.filecamp.com/s/d/NGJ58H6TtMJwKiwH) 2025/xx-xxxx-xxxx