Field safety notices - 20 to 24 April 2015
List of field safety notices (FSNs) from medical device manufacturers from 20 to 24 April 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
View the latest FSNs
Bard Peripheral Vascular: Bard Max-Core disposable core biopsy instrument
FA2015-15
Device description: surgical instruments, minimal access
MHRA reference: 2015/004/015/291/008
Biosensors Europe: Chroma coronary bare metal stent (BMS) system
17 April 2015
Device description: implants, non-active, coronary artery stents
Model: BCR-2733
MHRA reference: 2015/004/020/291/010
CardioKinetix: PARACHUTE guide catheter, delivery system, implant
09 April 2015
Device description: cardiac structural support or adaptation devices
Model: PGC68, PGC35, PDS68, 65mm
MHRA reference: 2015/004/020/291/007
Dako Denmark: Dako Omnis
Notification CAPA 00509
Device description: IVDs, cytopathology and histopathology
Model: Dako Omnis (GI100)
MHRA reference: 2015/004/022/291/010
Depuy Synthes: TFN-ADVANCED proximal femoral nailing system
17 April 2015
Device description: osteosynthesis, nails, intramedullary
MHRA reference: 2015/004/021/291/005
Medtronic: DBS extension kit
April 2015
Device description: implants, active, leads, neuro
Model: 37085, 37086 and 37087
MHRA reference: 2015/004/020/291/006
Roche Diagnostics: D-DI2 / D-Dimer Gen.2.
20 April 2015
Device description: coagulation
MHRA reference: 2015/004/022/071/001
Siemens Healthcare Diagnostics Products: BCS System / BCS XP System
April 2015
Device description: IVDs, clinical chemistry
Model: SMN: 10454742,10454729,10461894,10470625
MHRA reference: 2015/004/023/291/003
Smiths Medical International: Portex® Bivona® inner cannula for Bivona® adult tracheostomy tubes
17 April 2015
Device description: tube, tracheostomy
Model: BRC270, BRC275, BRC280, BRC285, BRC290, BRCA70, BRCA75, BRCA80, BRCA85, BRCA90
MHRA reference: 2015/004/016/291/004
Stryker Instruments: CBCII double and curved wound drains
20 April 2015
Device description: wound drains
MHRA reference: 2015/004/013/291/002