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 a list of

View . FSNs before this date are on the

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:

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

13 January 2022

Dialysis, haemodialysis

MHRA reference:

B. Braun Medical: Perfusor Space

11 January 2022

Infusion systems

Model: 8713030

MHRA reference:

Becton Dickinson: Veritor Plus System Analyzer

13 January 2022

IVDs, clinical chemistry

MHRA reference:

DIXI MEDICAL S.A.S: Microdeep depth electrode

22 November 2022

Implantable EEG

MHRA reference:

IMMY: Cryptococcus Antigen Lateral Flow Assay

3 January 2022

IVDs, bacteriology

Model: CR2003

MHRA reference:

Medtronic: Endurant II/IIs Stent Graft System

13 January 2022

IVDs, clinical chemistry

MHRA reference:

Microgenics Corporation (Thermofisher): QMS Tacrolimus Immunoassay Calibrator kit

13 January 2022

IVDs, clinical chemistry

MHRA reference:

Philips: CVX-300 Laser

December 2021

Therapy, lasers

Model: CVX-300

MHRA reference:

Roche: Elecsys CA 19-9

December 2021

IVDs, clinical chemistry

MHRA reference:

Ventana Medical Systems (Roche): BENCHMARK ULTRA

SBN-RDS-Pathology Lab-2022-001

IVDs, Cytopathology & Histopathology

MHRA reference:

Ventana Medical Systems (Roche): BENCHMARK ULTRA

SBN-RDS-Pathology Lab-2022-001

IVDs, Cytopathology & Histopathology

Model: 05342716001

MHRA reference:

Updates to this page

Published 25 January 2022