Field safety notice - 28 March to 01 April

List of field safety notices (FSNs) from medical device manufacturers from 28 March to 01 April.

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

Abbott Laboratories: CELL-DYN Emerald Cleaner

24 March 2016

IVDs, haematology

MHRA reference: 2016/003/029/291/002

Becton, Dickinson & Company, BD Biosciences: BD Retic-Count

22 March 2016

IVDs, haematology

Model: 349204

MHRA reference: 2016/003/031/601/007

Ariane Medical Systems: Papillon 50 X-ray therapy (brachytherapy) system

23 March 2016

Radiotherapy, afterloading

Model: Papillon 50, 180-001

MHRA reference: 2016/003/029/291/001

Boston Scientific: Fetch 2 Aspiration Catheter

26 March 2016

Vascular cannula and catheters

MHRA reference: 2016/003/029/291/004

James Leckey Design: Mygo Stander

24 March 2016

Moving and handling

Model: MYST 143

MHRA reference: 2015/012/023/601/010

Kimal Plc: VAXCEL PICC, XCELA PICC & BIOFLO PICC Technology Kits

18 March 2016

Vascular cannula and catheters

Model: 45-436, 45-455, 45-464, 45-470, 45-474, 45-479 & 45-841

MHRA reference: 2016/003/024/601/003

Össur: Lil’Angel Halo Vest

01 March 2016

Orthoses

MHRA reference: 2016/003/031/291/006

Össur: products with natural rubber latex

Recall 012016

Orthoses

Model: Knee Undersleeve Gray, NecLoc® Extrication Collar (Lot numbers before MX151001), Rebound® Cartilage, Rebound® Air Walker, Rebound® Diabetic Walker

MHRA reference: 2016/003/029/291/013

Össur: Miami J Collar

Recall 012016

Orthoses

Model: Miami J Collar

MHRA reference: 2016/003/024/292/008

Philips Healthcare: Allura Xper, AlluraClarity, Allura CV, Allura Centron, UNIQ and Integris systems

15 March 2016

X-ray, Fluoroscopy Systems

MHRA reference: 2015/011/017/292/009

Research Instruments: Power supply cable for the Integra 3 micromanipulator

11 March 2016

Surgical instruments, manipulating

MHRA reference: 2016/003/024/292/006

Siemens Healthcare: SOMATOM FORCE

11 March 2016

Computed Tomography

Model: 10742326

MHRA reference: 2016/003/031/601/004

Thermofisher Scientific: Oxoid Antimicrobial Susceptibility Test disc. Ticarcillin/Clavulanic Acid (TIM85)

24 March 2016

IVDs, bacteriology

Model: (TIM85) (CT0449)

MHRA reference: 2016/003/024/601/005

ThermoFisher Scientific: Recapper

23 March 2016

IVDs, clinical chemistry

MHRA reference: 2016/003/024/701/013

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