Field Safety Notice - 28 to 31 August
List of field safety notices (FSNs) from medical device manufacturers from 28 August to 31 August
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 FSN
View the latest FSNs
Acumed: Broken 2.7 CO Trephine
20 August 2018
Orthopaedic surgical instruments - Insertion/extraction tools
Model: Broken 2.7 CO Trephine 80-0217
MHRA reference: 2018/008/029/291/012
B Braun: Perifix® Catheter Connector
12 July 2018
Infusion & transfusion, administration sets
MHRA reference: 2018/007/005/601/014
CME McKinley: 100-100SM T34 Ambulatory Syringe Pump
29 August 2018
Infusion systems
MHRA reference: 2018/002/026/291/004
Covidien: Covidien EEA™ Circular Stapler with Tri-Staple™ Technology
August 2018
Staples and staple guns
Model: TRIEEAA28MT, TRIEEA28XT, TRIEEA31MT, TRIEEA31XT
MHRA reference: 2018/008/030/081/005
Degania Silicone: Mon-a-Therm™ Foley catheters with temperature sensors
26 July 2018
Urinary catheters and accessories
MHRA reference: 2018/008/028/291/022
Fannin: Staph/Strep Selective Agar Modified
24 August 2018
IVDs, bacteriology
MHRA reference: 2018/008/027/601/002
Hitachi (Roche)
August 2018
IVDs, clinical chemistry
MHRA reference: 2018/008/025/701/001
IBL International: Taenia solium IgG ELISA
23 August 2018
IVDs, clinical chemistry
MHRA reference: 2018/008/024/701/020
Intuitive Surgical: da Vinci® EndoWrist® Monopolar Curved Scissors
ISIFA2018-11-C
Surgical instruments, articulated cutting
Model: 420179-16; 470179-14
MHRA reference: 2018/008/028/701/003
Medtronic: Activa PC+S Implantable Neurostimulator (INS)
August 2018
Implants, active, stimulators, neuro
MHRA reference: 2018/008/030/081/001
Roche: CoaguChek
22 August 2018
Coagulation
MHRA reference: 2018/008/023/291/010
Roche
August 2018
IVDs, clinical chemistry
Model: Accu-Chek Inform II, cobas h 232, CoaguChek Pro II, CoaguChek XS Plus / XS Pro systems
MHRA reference: 2018/008/027/701/022
Thermo Fisher Scientific: Gibco™: MEM NEAA
13 August 2018
IVDs, bacteriology
MHRA reference: 2018/008/029/291/013
Zimmer Biomet: Disposable Juggerknot Long Drill Bit with Centerin
24 August 2018
Orthopaedic surgical instruments - cutting tools
MHRA reference: 2018/008/024/701/012
Zimmer Biomet: T.E.S.S Glenoid Drill 5mm
27 August 2018
Surgical power tools
MHRA reference: 2018/008/028/004