Field Safety Notices - 22 - 26 August 2016
Summary List of field safety notices (FSNs) from medical device manufacturers from 22 - 26 August 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
View the latest FSNs
Beckman Coulter: UniCel DxH 800/600 Cellular Analysis Systems
17 August 2016
IVDs, haematology
MHRA reference: 2016/008/018/601/002
BIOMET: OPTIPAC 40 & 60 REFOBACIN BONE CEMENT R
17 August 2016
Bone cement and tools
MHRA reference: 2016/008/022/701/007
Focus Diagnostics: Simplexa™ Flu A/B & RSV Direct, Integrated Cycler
6 May 2016
IVDs, viral microbiology
MHRA reference: 2016/008/018/299/014
JRI Orthopaedics: AEON Hip System
22 August 2016
Joint prosthesis, hip
Model: AEON Hip System Stems: 0510005, 0510015, Cups: 0341240, 0341242
MHRA reference: 2016/008/019/291/008
Medicrea International: Medicrea International
A08100200
Spinal implants
MHRA reference: 2016/006/001/299/014
Nalge Nunc International: Linear Barcoded Tubes - Cryogenic specimen container IVD, sterile
9 August 2016
IVDs, cytopathology & histopathology
MHRA reference: 2016/008/023/299/013
Ortho-Clinical: VITROS GLU; LAC: TRIG & URIC Slides
12 August 2016
IVDs, clinical chemistry
MHRA reference: 2016/008/018/601/008
Panthera: Panthera S3, Panthera S3 short, Panthera U3
16 June 2016
Wheelchairs, manual
Model: 548XX00BLG, 548XX00BLG, 548XX00BLG
MHRA reference: 2016/007/027/299/016
Pennine Ryles Tube - Various
23 August 2016
Feeding systems and tubes
MHRA reference: 2016/008/024/291/001
Sage Products: Comfort Shield® Barrier Cream Cloths
23 August 2016
Barrier creams & sprays
Model: 7526-X (24-pk), 7453-X (3-pk), 7905-X (8-pk)
MHRA reference: 2016/008/025/291/006
Siemens: RAPIDPoint®
August 2016
IVDs, extra laboratory testing
MHRA reference: 2016/008/018/601/009
Siemens: Dimension® and Dimension Vista® AADVIA® Chemistry Systems, Syva®
19 August 2016
IVDs, clinical chemistry
MHRA reference: 2016/008/023/601/002
Sorin Group: PLATINIUM
August 2016
Implants, active, defibrillators
Model: PLATINIUM VR 1210, VR 1240, DR 1510, DR 1540, CRT-D 1711, CRT-D 1741, SONR CRT-D 1811, SONR CRT-D 1841
MHRA reference: 2016/008/023/299/011
Stryker: Cup Positioner / Impactor Handle Assembly
18 August 2016
Orthopaedic surgical instruments - Impacting tools
Model: 2101-0200
MHRA reference: 2016/008/025/291/021