Field Safety Notices: 19 to 23 April 2021
Summary list of field safety notices (FSNs) from medical device manufacturers from 19 April to 23 April 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
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Abbott: EnSiteX EP System Amplifier
21 April 2021
Therapy tissue ablation
Model: ENSITE-AMP-02, ENSITE-R-AMP-02
MHRA reference:
Endo Tools Therapeutics: Endomina v2
19 April 2021
Sutures
Model: IA-EM8616610505-00
MHRA reference:
F.M. S.p.A: BLOODLINES AND ACCESSORIES FOR HEMODIALYSIS, HEMODIAFILTRATION AND HEMOFILTRATION.
INFUSION SETS AND TRANSFUSION SETS
SCLAP VEIN SETS, NEEDLES FOR BLOOD SAMPLING
FSN-01-2021
Dialysis, blood lines
MHRA reference:
Fuji Systems: Sterilized Drape for PDE
15 April 2021
Surgical drapes, gowns, masks
Model: 0823802
MHRA reference:
Henry Schein: IV Sets/Accessories
09 April 2021
Infusion & transfusion, administration sets
MHRA reference:
Hitachi:
31 March 2021
Ultrasound, imaging
Model: ALOKA ARIETTA 850, ARIETTA 750VE, ARIETTA 750SE
MHRA reference:
JRI Orthopaedics: Bi-Polar Trial Head
13 April 2021
Joint prosthesis, hip
Model: 48mm O\D
MHRA reference:
Medical Wire & Equipment: Dryswab
20 April 2021
IVDs, SARS-CoV-2 PCR test
Model: MW012
MHRA reference:
RanD:
14 April 2021
Blood/Fluid warming systems
Model: Disposable devices and accessories for hyperthermic Perfusion treatments for use with PERFOMER HT and PERFORMER LRT equipment
MHRA reference:
Teleflex: TracFlex Plus Tracheostomy Tube Set, Cuffed TracFlex Plus PDT Set
20 April 2021
Airway devices
MHRA reference:
VitreQ:
21 April 2021
Surgical, cryogenic
Model: CT00.D01
MHRA reference:
Welch Allyn: ProBP 3400 and GS777 Wall Transformer
WA-MOD1329-XXXX
Blood pressure monitor
Model: 34XFHT-B 77710
MHRA reference: