Field Safety Notices: 21 to 25 August 2023
Source: gov.uk (2025-01-16)

List of Field Safety Notices from 21 to 25 August 2023

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/FDCyFD2AJ9XJj9c1)

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)

Philips: Xper Flex Cardio Device

23 August 2023 Physiomonitoring System and Philips Hemo System Model: FC2010 & FC2020 MHRA reference: 27355833 (https://mhra-gov.filecamp.com/s/d/i4X5370e1chzkUaf) Distributor Letter - 2023/009/004/601/016 MHRA reference: 27355833 (https://mhra-gov.filecamp.com/s/d/xvth8oXyBgezhEmz) FSN

Abbott: Apical Coring Knife

August 2023 Heart Ventricle Prosthesis Model: 106524INT MHRA reference: 24572577 (https://mhra-gov.filecamp.com/s/d/Op3kXlRXyaQxSFqE)

B Braun Medical: Infusomat Space

August 2023 Bedside infusion pump, single-channel MHRA reference: 23831841 (https://mhra-gov.filecamp.com/s/d/5wGo61xPcsbo3jRJ)

B Braun Medical: Spaceplus Infusomat

August 2023 Bedside infusion pump, single-channel MHRA reference: 23363353 (https://mhra-gov.filecamp.com/s/d/GEvWA10AsvlXgWiD)

DePuy Synthes: BioKnotless Anchor

April 2023 Model: 212724, 212725, 212726, 212722, 212723 MHRA reference: 22192340 (https://mhra-gov.filecamp.com/s/d/A5muoJcDetFLspnl)

Drager: Babyroo TN300

August 2023 Infant Warmer MHRA reference: 20503932 (https://mhra-gov.filecamp.com/s/d/UW4yt5xyZ4xfvPZQ)

Getinge: MEERA operating table with autodrive

August 2023 Universal operating table, electrohydraulic Model: 7200.01B2, 7200.01F2, 7100.01B2 MHRA reference: 13515945 (https://mhra-gov.filecamp.com/s/d/7pw5hEGEhf4Biykl)

Invivoscribe: LymphoTrack Dx IGH - MiSeq

August 2023 Model: 91210109 - LymphoTrack Dx IGH FR3 Assay - Kit A - MiSeq, 91210119 - LymphoTrack Dx IGH FR3 Assay - Panel - MiSeq, 91210129 - LymphoTrack Dx IGH FR1/2/3 Assay - Kit A - MiSeq, 91210139 - LymphoTrack Dx IGH FR1/2/3 Assay - Panel - MiSeq MHRA reference: 25619485 (https://mhra-gov.filecamp.com/s/d/WUx67qGAZnHVmNc4)

Medline International France: Hudson RCI AQUAPAK Humidifier Adaptors

August 2023 MHRA reference: 22072866 (https://mhra-gov.filecamp.com/s/d/0UpNcJpw805v7ZfK)

Medtronic: Palindrome Chronic Catheter Kit Symmetrical Tip 14

August 2023 Double-lumen haemodialysis catheter, implantable Model: xx-xxxx-xxxx MHRA reference: 23404435 (https://mhra-gov.filecamp.com/s/d/xB5LtuLo44sSd1a6)

Ossur: Icelock Ratchets

April 2023 Extern lower-limb prosthesis suspensory component Model: L-125000; L-621200; L-621000; L-621100; L-692020 MHRA reference: 20293768 (https://mhra-gov.filecamp.com/s/d/pOZyBzh7GdO3bQLp)

Revvity: Vanadis Extract Reaction Plates

August 2023 Model: 4306-0010 MHRA reference: 20341036 (https://mhra-gov.filecamp.com/s/d/815RD2i51w4iRjiS)

Smiths Medical: Medfusion syringe infusion pumps

August 2023 Model: 3500, 4000 MHRA reference: 21983249 (https://mhra-gov.filecamp.com/s/d/3wXAVaE059IWeJNT)

Wom: Aquilex Fluid Control System

July 2023 Hysteroscopic irrigation/insufflation system Model: AQL-100PBS and AQL-100P MHRA reference: 8914228 (https://mhra-gov.filecamp.com/s/d/AjFNhyjTQeSgiJUi)

Xiamen Compower Medical: Compower

CP 2023-1_ Compower PVC Manual Resuscitator Model: YA-3#+M5 MHRA reference: 20540311 (https://mhra-gov.filecamp.com/s/d/04pkdZXZaR13MMWv)