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