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.
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FSNs before this date are on the
Aspire Pharma: Epimax Original Cream 500g
17 November 2021
Barrier creams & sprays
MHRA reference:
Convatec: Gentlecath Air Female
14 October 2021
Urinary catheters and accessories
MHRA reference:
Cook Medical: Flexor Check-Flo Introducer 鈥� Ansel Modification
12 November 2021
Vascular cannula and catheters
MHRA reference:
Guangdong Baihe Medical Technology: Rheovalves Disposable Needle-Free Valve
25 October 2021
Infusion & transfusion, connectors
Model: RVNF1
MHRA reference:
Hain Lifesciences: GenoType MTBDRplus V. 2.0 / GenoType MTBDRsl V.2.
20 October 2021
IVDs, bacteriology
MHRA reference:
Ivoclar: ProBase Cold Monomer
25 October 2021
Dental materials
Model: 00 mL; 1000 mL
MHRA reference:
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:
Medtronic: StealthStation Cranial and Synergy Cranial
November 2021
Surgical navigation system and accessories
Model: 9733763, 9735585
MHRA reference:
Thermo Fisher: TaqPath Covid-19 CE-IVD RT-PCR Ki
PR#518365
IVDs, SARS-CoV-2 PCR test
Model: A48067 and A51738
MHRA reference:
Tosoh: Hemoglobin F and A2 Control
9 October 2021
IVDs, haematology
MHRA reference:
Tridentify: QTA Tracer 2.0
16 November 2021
MHRA reference: 33754078