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

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