Field Safety Notices: 28 November to 2 December 2022
List of Field Safety Notices (FSNs) from 28 November to 2 December 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 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
Integra: SURGICAL PATTIES 1/2 X 1/2
28 November 2022
Neurosurgical sponge
MHRA reference: 5132443.
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