Field Safety Notices - 29 June to 03 July 2020
Summary list of field safety notices (FSNs) from medical device manufacturers from 29 June to 03 July 2020
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
View a
View
FSNs before this date are on the
Bard (Becton Dickinson): BARD SafeStep鈩� Huber Needle Sets
24 June 2020
Infusion & transfusion, administration sets
MHRA reference:
Beckman Coulter: DxA 5000
23 June 2020
IVDs, clinical chemistry
MHRA reference:
Becton Dickinson: BD PosiFlush鈩� XS 10mL Syringe
01 July 2020
Vascular cannula/catheter accessories
MHRA reference:
Biosense Webster: CARTO 3 System Version V7.1.80, CARTO VISITAG
V7.1.80
皇冠体育apprapy tissue ablation
MHRA reference:
Biosensors Europe: BioPath 014 and BioPath 035
15 June 2020
Vascular cannula and catheters
Model: BPTH-14-xxxx; BPTH-35-xxxx
MHRA reference:
CARDIONOVUM: LEGFLOW OTW Paclitaxel Releasing Peripheral Balloon Dilatation Catheter
June 2020
Vascular cannula and catheters
Model: All LEGFLOW OTW and RX models
MHRA reference:
Magstim: Neurosign V4
22 June 2020
Stimulators diagnostic
MHRA reference:
Project Engineering: MostCare UP
18 June 2020
Monitors, patient
Model: 08MC02
MHRA reference:
Randox Laboratories: RANDOX LIPASE (LPS)
22 June 2020
IVDs, clinical chemistry
Model: LI3837, LI7979, LI8050, LI8361
MHRA reference:
Randox Laboratories: RANDOX SOLUBLE TRANSFERRIN RECEPTORS CALIBRATOR SERIES & CONTROLS
29 June 2020
IVDs, clinical chemistry
MHRA reference:
Roche Diagnostics: Elecsys Troponin T hs
June 2020
IVDs, clinical chemistry
MHRA reference:
Sentinel Diagnostics: Fructosamine
25 June 2020
IVDs, clinical chemistry
MHRA reference:
Siemens Healthcare: Atellica IM 1300 and IM 1600 Analyzers
May 2020
IVDs, clinical chemistry
MHRA reference:
皇冠体育apprmo Fisher Scientific: Applied Biosystems庐 COVID-19 Interpretive Software
PR 430675
IVDs, sars-cov-2 pcr test
Model: 100093007; version 1.0 and 100093343; version 1.1
MHRA reference:
Becton Dickinson: Lubri-Sil庐 Bard庐 Tray - Foley Catheterisation Tray
02 July 2020
Urinary catheters and accessories
Model: NGDT2571
MHRA reference: