Field safety notices - 18 April to 22 April 2016
List of field safety notices (FSNs) from medical device manufacturers from 18 April to 22 April 2016
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
Biomet: M2A 38mm Acetabular System - all cups and heads
12 April 2016
Joint prosthesis, hip
MHRA reference: 2016/004/015/701/004
Biosense Webster: PentaRay® Nav Catheter, PentaRay® Nav eco Catheter
14 April 2016
Vascular cannula and catheters
MHRA reference: 2016/004/018/081/001
Bridge to Life: Belzer UW(R) Cold Storage Solution
15 April 2016
Storage & collection devices MHRA reference: 2016/004/015/601/006
CARDIONOVUM: LEGFLOW OTW
25 March 2016
Vascular cannula and catheters
MHRA reference: 2016/004/014/299/004
CSC “MedSil”
21 January 2016
IVDs, clinical chemistry
Model: Build 6 and above
MHRA reference: 2016/001/027/292/009
Clinical Innovations: Ebb Complete Tamponade System
9 July 2016
Surgical instruments, minimal access
Model: CTS-1000
MHRA reference: 2016/004/015/299/016
DiaMed: ID-Papain
13 April 2016
IVDs, blood transfusion
Model: 06311
MHRA reference: 2016/004/019/701/002
GCE
11 April 2016
Resuscitators
Model: MARS II 0715212 and 0715216
MHRA reference: 2016/004/011/601/006
Haemonetics: Cell Saver Elite processing kit (225 mL)
15 April 2016
Infusion & transfusion, autologous
MHRA reference: 2016/004/019/701/003
Hologic: ThinPrep 5000 Processor with Autoloader
7 March 2016
IVDs, cytopathology & histopathology
Model: ASY-03098
MHRA reference: 2016/004/014/299/010
Hospira Plum A+ Infusion Pump, Plum 360 Infusion pump
13 April 2016
Infusion systems
MHRA reference: 2016/004/001/292/001
Intervene: Surety Introducer Needle 19G 38mm
8 April 2016
Injection devices
MHRA reference: 2016/004/014/299/005
Randox Laboratories: Magnesium on RX Daytona+ analyser
15 March 2016
IVDs, clinical chemistry
Model: MG8326
MHRA reference: 2016/004/015/601/003
Siemens: Artis one
29 January 2016
X Ray, fluoroscopy systems
Model: Artis one 10848600
MHRA reference: 2016/004/006/601/003
Smiths Medical: Medex ™ Cardiothoracic Custom sets
7 April 2016
Vascular cannula and catheters
MHRA reference: 2016/004/015/299/006
Völker : Völker-Bett 2080
C-0000275568
Beds and accessories
MHRA reference: 2015/011/019/291/010