Field Safety Notice - 26 February – 02 March 2018
Summary List of field safety notices (FSNs) from medical device manufacturers from 26 February – 02 March 2018
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
Becton Dickinson: BD OneFlow™ B-CLPD T1
23 February 2018
IVDs, immunology
MHRA reference: 2018/002/028/478/002
Draeger Medical Systems: Infinity Acute Care System (M540)
February 2018
Monitors, patient
MHRA reference: 2018/002/026/291/006
Draeger: Fabius GS Premium, Tiro, Tiro D-M, MRI, plus, plus
February 2018
Anaesthetic machines & monitors
Model: 8607000, 8606000, 8608400, 8607300, 8606800, 8608555
MHRA reference: 2018/002/027/478/016
Edwards Lifesciences LLC: Intro-Flex® Percutaneous Sheath Introducers [Set]
FCA-86
Vascular cannula/catheter accessories
Model: I300F85
MHRA reference: 2017/011/024/228/006
Hill-Rom: PROGRESSA BED SYSTEM
MOD1278
Beds and accessories
Model: P7500A
MHRA reference: 2018/002/028/291/007
Immucor GTI Diagnostics: MATCH IT! DNA software
31 January 2018
IVDs, immunology
MHRA reference: 2018/002/022/478/018
Merit Medical Systems Inc: Pericardiocentesis Kit
February 2018
Chest drains and accessories
MHRA reference: 2018/002/023/478/013
Physio-Control: LIFEPAK® 20e defibrillator/monitor
February 2018
Defibrillators, non implantable
Model: 3317222-000 (PCBA)
MHRA reference:2018/002/009/701/015
Radiometer Medical: AQURE system
FAN 915-378
IVDs, extra laboratory testing
MHRA reference: 2018/002/026/478/017
Randox Laboratories: Lipase
16 February 2018
IVDs, clinical chemistry
Model: LI3837, LI7979, LI8050, LI8361
MHRA reference: 2018/002/027/601/004
Richardson Healthcare
20 February 2018
Basic dressings, absorbents, swabs, procedure packs
MHRA reference: 2018/002/022/601/004
Siemens Healthcare Diagnostic: Various analytes
February 2018
IVDs, Clinical Chemistry
MHRA reference: 2017/012/015/601/010
SybronEndo: Elements Obturation Unit
27 December 2017
Dental materials
Endotontic filling material
MHRA reference: 2018/001/003/701/007