Field Safety Notices: 26 to 30 September 2022

Summary List of field safety notices (FSNs) from medical device manufacturers from 26 to 30 September 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

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View . FSNs before this date are on the

B Braun Medical: OM760SU SINGLE USE SURGICAL INSTR.

27 September 2022

Surgical Instruments, Minimal Access

MHRA reference:

Baxter: Prismaflex HF1000 set, Prismaflex HF1400 set, Prismaflex HF20 set, Prismaflex M100 set, Prismaflex M150 set, Prismaflex M60 set, Prismaflex ST100 set, Prismaflex ST150 set, Prismaflex ST60 set

September 2022

Dialysis, Blood Lines

MHRA reference:

CareDx: QTYPE 11

23 September 2022

IVDs, Immunology

MHRA reference:

Cooper Surgical: Humidifier Bottle and Syringe filter kit for BT37

12 July 2022

Laboratory Equipment Associated With IVF, Cells, Tissues

MHRA reference:

DiaMed: 001500 / 001500RECOND IH-500

23 September 2022

IVDs, Cytopathology & Histopathology

MHRA reference:

GE Healthcare: 9100c NXT

Ref 34131

Anaesthetic Machines & Monitors

MHRA reference:

Invacare: Action 4NG heavy duty

26 September 2022

Wheelchairs, Manual

MHRA reference:

Merit Medical Systems: CorVocet Biopsy System

12 August 2022

Surgical Instruments, Minimal Access

MHRA reference:

Siemens Healthcare GmBH: ARTIS pheno

September 2022

X Ray, Fluoroscopy Systems

MHRA reference:

Thermo Fisher Scientific: TaqPath鈩� COVID鈥�19 HT Kit

21 September 2022

IVDs, SARS-CoV-2 PCR Test

Model: A50883

MHRA reference:

Updates to this page

Published 3 October 2022