Field Safety Notices: 15 to 19 November 2021

List of field safety notices (FSNs) from medical device manufacturers from 15 to 19 November 2021

From:
Medicines and Healthcare products Regulatory Agency
Published
24 November 2021
Message type:
Field safety notice
Issued:
24 November 2021

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

Aspire Pharma: Epimax Original Cream 500g

17 November 2021

Barrier creams & sprays

MHRA reference: 2021/011/017/579/004

Convatec: Gentlecath Air Female

14 October 2021

Urinary catheters and accessories

MHRA reference: 2021/011/015/291/014

Cook Medical: Flexor Check-Flo Introducer – Ansel Modification

12 November 2021

Vascular cannula and catheters

MHRA reference: 2021/011/015/291/016

Guangdong Baihe Medical Technology: Rheovalves Disposable Needle-Free Valve

25 October 2021

Infusion & transfusion, connectors

Model: RVNF1

MHRA reference: 2021/011/010/291/001

Hain Lifesciences: GenoType MTBDRplus V. 2.0 / GenoType MTBDRsl V.2.

20 October 2021

IVDs, bacteriology

MHRA reference: 2021/011/015/291/013

Ivoclar: ProBase Cold Monomer

25 October 2021

Dental materials

Model: 00 mL; 1000 mL

MHRA reference: 2021/011/003/579/009

Jafron Biomedical: Disposable Hemoperfusion Cartridge (HA)

15 September 2021

Infusion systems

Model: HA60, HA80, HA100, HA130, HA150, HA180, HA230, HA280, HA330, HA330-II, HA380, HA430, HA480

MHRA reference: 2021/011/017/579/003

Medtronic: StealthStation Cranial and Synergy Cranial

November 2021

Surgical navigation system and accessories

Model: 9733763, 9735585

MHRA reference: 2021/011/017/579/005

Thermo Fisher: TaqPath Covid-19 CE-IVD RT-PCR Ki

PR#518365

IVDs, SARS-CoV-2 PCR test

Model: A48067 and A51738

MHRA reference: 2021/011/010/579/007

Tosoh: Hemoglobin F and A2 Control

9 October 2021

IVDs, haematology

MHRA reference: 2021/011/015/291/017

Tridentify: QTA Tracer 2.0

16 November 2021

MHRA reference: 33754078

Updates to this page

Published 24 November 2021
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