Field safety notices - 26 to 30 October 2015

List of field safety notices (FSNs) from medical device manufacturers from 26 to 30 October 2015.


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

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

Published 30 October 2015