Field safety notices - 26 to 30 October 2015
List of field safety notices (FSNs) from medical device manufacturers from 26 to 30 October 2015.
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
Arrow International: PICC kits with Glidethru component
26 October 2015
Vascular cannula and catheters
MHRA reference: 2015/010/027/131/004
Beckman Coulter: Access CEA reagent kit
22 October 2015
IVDs, clinical chemistry
Model: Access CEA
MHRA reference: 2015/010/022/601/013
Cook Group Incorporated: CXI® support catheter
28 October 2015
Vascular cannula and catheters
MHRA reference: 2015/010/029/292/007
Covidien: Covidien Palindrome™ catheters
27 October 2015
Vascular cannula and catheters
MHRA reference: 2015/010/027/701/001
Depuy Synthes: USS universal spine system
20 October 2015
Spinal implants
Model: 04.607.054, 499.615, and 04.636.755
MHRA reference: 2015/010/028/291/003
Hammarplast Medical: Hpm roll-on cuff
12 October 2015
Surgical equipment, tourniquets
Model: 3746
MHRA reference: 2015/010/027/291/011
Invatec (Medtronic): Amphirion deep PTA Balloon dilation catheter
October 2015
Vascular cannula and catheters
MHRA reference: 2015/010/026/291/002
Johnson & Johnson: Ethicon PowerStar bipolar cable
19 October 2015
Surgical, diathermy
Model: BP930, BP940
MHRA reference: 2015/010/007/701/007
Mediplus Ltd: Urethral pressure profile catheter, 8Fr
29 October 2015
Urinary catheters and accessories
Model: 5300
MHRA reference: 2015/010/029/292/019
Newdeal SAS (Integra): BOLD 2.5mm compression screw
October 2015
Osteosynthesis, bone screws
Model: 200010, 200010S, 200016, 200016S
MHRA reference: 2015/010/023/291/004
Ortho Clinical Diagnostics: ORTHO VISION™ Analyzer for ORTHO BioVue ®
October 2015
IVDs, blood transfusion
Model: 6904579
MHRA reference: 2015/010/008/601/002
Precision UK: CPX medical gas manifolds for breathing gases
12 October 2015
Anaesthetic & breathing, medical gas pipelines
MHRA reference: 2015/010/013/601/006
Q Core Medical: Sapphire infusion pump
26 October 2015
Infusion systems
Model: 163123601
MHRA reference: 2015/006/025/401/013
Siemens Healthcare: SOMATOM Definition AS with patient table 1600
6 October 2015
Computed tomography
Model: Definition AS Mat.Nr 8098027 with table Mat.Nr. 10643655
MHRA reference: 2015/010/027/601/009
Thermofisher Scientific: Oxoid antimicrobial susceptibility testing disc CN10 gentamicin
28 October 2015
IVDs, bacteriology
MHRA reference: 2015/010/029/601/004
Toshiba Medical: CT scanner Aquilion PRIME
23 October 2015
Computed tomography
Model: Aquilion PRIME TSX-303A
MHRA reference: 2015/010/026/292/005