Field Safety Notices (FSNs) from 21 to 25 August 2023

List of Field Safety Notices (FSNs) 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

View a list of FSNs published since January 2020

View FSNs since November 2014. FSNs before this date are on the National Archives website

Abbott: Apical Coring Knife

August 2023

Heart Ventricle Prosthesis

Model: 106524INT

MHRA reference: 24572577

B Braun Medical: Infusomat Space

August 2023

Bedside infusion pump, single-channel

MHRA reference: 23831841

B Braun Medical: Spaceplus Infusomat

August 2023

Bedside infusion pump, single-channel

MHRA reference: 23363353

DePuy Synthes: BioKnotless Anchor

April 2023

Model: 212724, 212725, 212726, 212722, 212723

MHRA reference: 22192340

Drager: Babyroo TN300

August 2023

Infant Warmer

MHRA reference: 20503932

Getinge: MEERA operating table with autodrive

August 2023

Universal operating table, electrohydraulic

Model: 7200.01B2, 7200.01F2, 7100.01B2

MHRA reference: 13515945

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

Medline International France: Hudson RCI AQUAPAK Humidifier Adaptors

August 2023

MHRA reference: 22072866

Medtronic: Palindrome Chronic Catheter Kit Symmetrical Tip 14

August 2023

Double-lumen haemodialysis catheter, implantable

Model: 8888145015

MHRA reference: 23404435

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

Revvity: Vanadis Extract Reaction Plates

August 2023

Model: 4306-0010

MHRA reference: 20341036

Smiths Medical: Medfusion syringe infusion pumps

August 2023

Model: 3500, 4000

MHRA reference: 21983249

Wom: Aquilex Fluid Control System

July 2023

Hysteroscopic irrigation/insufflation system

Model: AQL-100PBS and AQL-100P

MHRA reference: 8914228

Xiamen Compower Medical: Compower

CP 2023-1_ Compower PVC Manual Resuscitator

Model: YA-3#+M5

MHRA reference: 20540311

Published 30 August 2023