Field Safety Notices: 11 to 15 April 2022
Summary List of field safety notices (FSNs) from medical device manufacturers from 11 to 15 April 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.
Arjo: Sara Plus
31 March 2022
Hoists and slings
Model: HEP0001, HEP2001
MHRA reference: 2022/003/028/601/502
Baxter: Flo-Thru Intraluminal Shunt
11 April 2022
Surgical devices, non-powered
MHRA reference: 2022/004/008/291/003
Breas: NIPPY 4 and NIPPY 4+
06 April 2022
Lung ventilators
Model: REF 226000, 231000
MHRA reference: 2022/004/006/601/002
Getinge: Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e
18 March 2022
Anaesthetic machines & monitors
MHRA reference: 2021/012/006/487/003
Ortho Clinical Diagnostics: VITROS Immunodiagnostic Products FSH Reagent Pack, Immunodiagnostic Products LH Reagent Pack & Immunodiagnostic Products Prolactin Reagent Pack
CL2022-069_EU URGENT
IVDs, clinical chemistry
Model: FSH -1931922, LH -1350198 & PROL-1849793
MHRA reference: 2022/003/031/601/002
Siemens Healthineers: Atellica IM/ADVIA Centaur Enhanced Estradiol (eE2)
March 2022
IVDs, clinical chemistry
MHRA reference: 2022/003/010/601/502
Sol-Millennium: SOL-M Blunt Fill Needle
31 March 2022
Injection devices
Model: Sterile
MHRA reference: 2022/004/006/291/001
Storz: Single channel flexible endoscopes with T-Luer 11XXX
07 April 2022
Endoscopes, flexible
MHRA reference: 2022/004/008/291/001