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