Field Safety Notices: 17 to 21 January 2022

List of field safety notices (FSNs) from medical device manufacturers from 17 to 21 January 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

Baxter Healthcare: MINICAP EXTEND LIFE PD TRANSFER SET MINICAP EXTD LIFE TRANSFER SET

18 January 2022

Dialysis, peritoneal

Model: 5C4482, R5C4482, R5C4483, R5C4484, R5C4482E

MHRA reference: 2022/001/020/487/002

B. Braun Avitum: Conductivity sensor spare part for Dialog machines

13 January 2022

Dialysis, haemodialysis

MHRA reference: 2022/001/014/601/501

B. Braun Medical: Perfusor Space

11 January 2022

Infusion systems

Model: 8713030

MHRA reference: 2022/001/011/601/500

Becton Dickinson: Veritor Plus System Analyzer

13 January 2022

IVDs, clinical chemistry

MHRA reference: 2022/001/011/291/001

DIXI MEDICAL S.A.S: Microdeep depth electrode

22 November 2022

Implantable EEG

MHRA reference: 2022/001/017/487/001

IMMY: Cryptococcus Antigen Lateral Flow Assay

3 January 2022

IVDs, bacteriology

Model: CR2003

MHRA reference: 2022/001/011/701/020

Medtronic: Endurant II/IIs Stent Graft System

13 January 2022

IVDs, clinical chemistry

MHRA reference: 2022/001/014/487/003

Microgenics Corporation (Thermofisher): QMS Tacrolimus Immunoassay Calibrator kit

13 January 2022

IVDs, clinical chemistry

MHRA reference: 2022/001/017/487/003

Philips: CVX-300 Laser

December 2021

Therapy, lasers

Model: CVX-300

MHRA reference: 2021/012/014/601/503

Roche: Elecsys CA 19-9

December 2021

IVDs, clinical chemistry

MHRA reference: 2021/003/011/487/008

Ventana Medical Systems (Roche): BENCHMARK ULTRA

SBN-RDS-Pathology Lab-2022-001

IVDs, Cytopathology & Histopathology

MHRA reference: 2022/001/017/487/004

Ventana Medical Systems (Roche): BENCHMARK ULTRA

SBN-RDS-Pathology Lab-2022-001

IVDs, Cytopathology & Histopathology

Model: 05342716001

MHRA reference: 2022/001/014/701/024

Published 25 January 2022