Field Safety Notices: 21 to 25 August 2023

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 . FSNs before this date are on the

Philips: Xper Flex Cardio Device

23 August 2023 Physiomonitoring System and Philips Hemo System Model: FC2010 & FC2020 MHRA reference: Distributor Letter - 2023/009/004/601/016 MHRA reference: FSN

Abbott: Apical Coring Knife

August 2023 Heart Ventricle Prosthesis Model: 106524INT MHRA reference:

B Braun Medical: Infusomat Space

August 2023 Bedside infusion pump, single-channel MHRA reference:

B Braun Medical: Spaceplus Infusomat

August 2023 Bedside infusion pump, single-channel MHRA reference:

DePuy Synthes: BioKnotless Anchor

April 2023 Model: 212724, 212725, 212726, 212722, 212723 MHRA reference:

Drager: Babyroo TN300

August 2023 Infant Warmer MHRA reference:

Getinge: MEERA operating table with autodrive

August 2023 Universal operating table, electrohydraulic Model: 7200.01B2, 7200.01F2, 7100.01B2 MHRA reference:

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:

Medline International France: Hudson RCI AQUAPAK Humidifier Adaptors

August 2023 MHRA reference:

Medtronic: Palindrome Chronic Catheter Kit Symmetrical Tip 14

August 2023 Double-lumen haemodialysis catheter, implantable Model: 8888145015 MHRA reference:

Ossur: Icelock Ratchets

April 2023 Extern lower-limb prosthesis suspensory component Model: L-125000; L-621200; L-621000; L-621100; L-692020 MHRA reference:

Revvity: Vanadis Extract Reaction Plates

August 2023 Model: 4306-0010 MHRA reference:

Smiths Medical: Medfusion syringe infusion pumps

August 2023 Model: 3500, 4000 MHRA reference:

Wom: Aquilex Fluid Control System

July 2023 Hysteroscopic irrigation/insufflation system Model: AQL-100PBS and AQL-100P MHRA reference:

Xiamen Compower Medical: Compower

CP 2023-1_ Compower PVC Manual Resuscitator Model: YA-3#+M5 MHRA reference:

Updates to this page

Published 16 January 2025