GovWire

Field Safety Notices: 28 November to 2 December 2022

Medicines Healthcare Products Regulatory Agency

December 5
15:12 2022

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: Alinity m Resp-4-Plex AMP Kit

22 November 2022

IVDs, Viral Microbiology

MHRA reference: 2022/011/025/701/018

Armstrong Medical: Catheter Mount Assembly

25 November 2022

Breathing System Components

Model: Double Swivel Elbow Version 01

MHRA reference: 2022/011/029/611/005

Baxter: REVACLEAR 300 Dialyzer, REVACLEAR 400 Dialyzer

28 November 2022

Dialysis, Haemodialysis

MHRA reference: 2022/011/029/611/001

BioIntegral Surgical: Brand

25 November 2022

Implants, Non Active, Cardiovascular Heart Valves

Model: NRAC, NRPC, NRA, NRM, NRIP

MHRA reference: 2022/004/021/291/004

Dentsply Sirona: Glyde File Prep Doses Pack

November 2022

Dental Appliances / Instruments

MHRA reference: 2022/011/008/701/069

Edwards: 120803FP, 120404FP, 120403FP, 120804FP, 120806FP

28 September 2022

Vascular Cannula And Catheters

MHRA reference: 2022/010/001/590/003

GE Healthcare: Centricity Universal Viewer Zero Footprint client

Ref 85460

Picture Archiving And Communication System (PACS)

MHRA reference: 2022/005/024/611/003

Getinge: Datascope Intra-Aortic Balloon Catheters (IABs)

05 August 2022

Cardiac Assist Pumps

MHRA reference: 2022/008/010/291/031

Medtronic: Guardian application

November 2022

Monitors, Patient

Model: MMT-8200, MMT-8201

MHRA reference: 2022/011/023/596/001

Olympus: ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE

29 November 2022

Endoscopes, Rigid

Model: LTF-190-10-3D

MHRA reference: 2022/011/014/611/001

Philips: 989803137631 Fetal Measurements

18 November 2022

Monitors, Foetal

MHRA reference: 2022/011/025/599/011

Published 5 December 2022

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