Field Safety Notices - 3 to 7 February 2020
Summary List of field safety notices (FSNs) from medical device manufacturers from 3 to 7 February 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 latest FSNs
Accriva Diagnostics: Hemochron Signature Elite
30 January 2020
Coagulation
Model: ELITE, ELITEINT
MHRA reference: 2020/002/003/487/002
AGFA: DR800
VR0000716
Computed tomography
MHRA reference: 2020/002/006/487/004
BioFire Diagnostics, LLC: FilmArray® Blood Culture Identification (BCID) Pan
January 2020
IVDs, bacteriology
Model: RFIT-ASY-0127 / RFIT-ASY-0126
MHRA reference: 2020/002/004/487/003
Boston Scientific: Imager™ 5F II Angiographic Catheter
92484513-FA
Vascular cannula and catheters
MHRA reference: 2020/002/006/487/003
CareFusion: Cardinal Health™ Surgical Gowns
24 January 2020
Surgical drapes, gowns, masks
MHRA reference: 2020/002/003/487/001
BD CME: T34 TM Ambulatory Syringe Pump
03 February 2020
Infusion systems
MHRA reference: 2020/001/016/487/009
Cook Medical: Hemospray Endoscopic Hemostat
17 January 2020
Haemostatic agents
MHRA reference: 2020/002/004/487/018
Fast Track Diagnostics: Various FTD Products (Update)
January 2020
IVDs, bacteriology
Model: Please refer to the FSN (Original version)
MHRA reference: 2019/012/016/291/017
GE Medical Systems: ApexPro Telemetry System
GEHC 36142
Monitors, patient
MHRA reference: 2020/001/027/228/006
Handicare: SwiftHook
20 December 2019
Hoists and slings
Model: 70200008
MHRA reference: 2019/012/024/487/001
Heraeus: PALAMIX® UNO, PALAMIX® DUO
31 January 2020 Bone cement and tools MHRA reference: 2020/002/004/487/019
Ormco Corporation: Snaplink Buccal Tube, 18° 0° 12°
16 January 2020
Dental appliances / instruments
MHRA reference: 2020/001/028/228/011
QIAGEN: Rotor-Gene Q
31 January 2020
IVDs, viral microbiology
MHRA reference: 2020/002/003/291/003
Shanghai Kindly Enterprises: Alaris® Extension Sets, Low Sorbing (PE)
03 February 2020
Infusion & transfusion, administration sets
Model: Alaris® Extension Sets, Low Sorbing (PE) - distributed by CareFusion (now part of BD)
MHRA reference: 2020/002/003/291/013
SOPRO
10 January 2020
X ray, dental imaging
Model: PSPIX
MHRA reference: 2020/001/020/487/020
Teleflex: Pilling CLEAR ADVANTAGE®
24 January 2020
Surgical instruments, articulated cutting
MHRA reference: 2020/001/030/487/001
Teleflex Medical: Arrow® EPIDURAL CATHETERIZATION Kits and Sets
30 January 2020
Injection devices
MHRA reference: 2020/002/003/291/001
Zimmer: Disposable Cylindrical Tourniquet Cuffs
30 January 2019
Surgical equipment, tourniquets
MHRA reference: 2020/002/003/291/002