Field safety notice - 28 March to 01 April 2016
List of field safety notices (FSNs) from medical device manufacturers from 28 March to 01 April.
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
Abbott Laboratories: CELL-DYN Emerald Cleaner
24 March 2016
IVDs, haematology
MHRA reference: 2016/003/029/291/002
Becton, Dickinson & Company, BD Biosciences: BD Retic-Count
22 March 2016
IVDs, haematology
Model: 349204
MHRA reference: 2016/003/031/601/007
Ariane Medical Systems: Papillon 50 X-ray therapy (brachytherapy) system
23 March 2016
Radiotherapy, afterloading
Model: Papillon 50, 180-001
MHRA reference: 2016/003/029/291/001
Boston Scientific: Fetch 2 Aspiration Catheter
26 March 2016
Vascular cannula and catheters
MHRA reference: 2016/003/029/291/004
James Leckey Design: Mygo Stander
24 March 2016
Moving and handling
Model: MYST 143
MHRA reference: 2015/012/023/601/010
Kimal Plc: VAXCEL PICC, XCELA PICC & BIOFLO PICC Technology Kits
18 March 2016
Vascular cannula and catheters
Model: 45-436, 45-455, 45-464, 45-470, 45-474, 45-479 & 45-841
MHRA reference: 2016/003/024/601/003
Össur: Lil’Angel Halo Vest
01 March 2016
Orthoses
MHRA reference: 2016/003/031/291/006
Össur: products with natural rubber latex
Recall 012016
Orthoses
Model: Knee Undersleeve Gray, NecLoc® Extrication Collar (Lot numbers before MX151001), Rebound® Cartilage, Rebound® Air Walker, Rebound® Diabetic Walker
MHRA reference: 2016/003/029/291/013
Össur: Miami J Collar
Recall 012016
Orthoses
Model: Miami J Collar
MHRA reference: 2016/003/024/292/008
Philips Healthcare: Allura Xper, AlluraClarity, Allura CV, Allura Centron, UNIQ and Integris systems
15 March 2016
X-ray, Fluoroscopy Systems
MHRA reference: 2015/011/017/292/009
Research Instruments: Power supply cable for the Integra 3 micromanipulator
11 March 2016
Surgical instruments, manipulating
MHRA reference: 2016/003/024/292/006
Siemens Healthcare: SOMATOM FORCE
11 March 2016
Computed Tomography
Model: 10742326
MHRA reference: 2016/003/031/601/004
Thermofisher Scientific: Oxoid Antimicrobial Susceptibility Test disc. Ticarcillin/Clavulanic Acid (TIM85)
24 March 2016
IVDs, bacteriology
Model: (TIM85) (CT0449)
MHRA reference: 2016/003/024/601/005
ThermoFisher Scientific: Recapper
23 March 2016
IVDs, clinical chemistry
MHRA reference:2016/003/024/701/013