Field safety notices - 18 April to 22 April 2016

List of field safety notices (FSNs) from medical device manufacturers from 18 April to 22 April 2016

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

Biomet: M2A 38mm Acetabular System - all cups and heads

12 April 2016

Joint prosthesis, hip

MHRA reference: 2016/004/015/701/004

Biosense Webster: PentaRay® Nav Catheter, PentaRay® Nav eco Catheter

14 April 2016

Vascular cannula and catheters

MHRA reference: 2016/004/018/081/001

Bridge to Life: Belzer UW(R) Cold Storage Solution

15 April 2016

Storage & collection devices MHRA reference: 2016/004/015/601/006

CARDIONOVUM: LEGFLOW OTW

25 March 2016

Vascular cannula and catheters

MHRA reference: 2016/004/014/299/004

CSC “MedSil”

21 January 2016

IVDs, clinical chemistry

Model: Build 6 and above

MHRA reference: 2016/001/027/292/009

Clinical Innovations: Ebb Complete Tamponade System

9 July 2016

Surgical instruments, minimal access

Model: CTS-1000

MHRA reference: 2016/004/015/299/016

DiaMed: ID-Papain

13 April 2016

IVDs, blood transfusion

Model: 06311

MHRA reference: 2016/004/019/701/002

GCE

11 April 2016

Resuscitators

Model: MARS II 0715212 and 0715216

MHRA reference: 2016/004/011/601/006

Haemonetics: Cell Saver Elite processing kit (225 mL)

15 April 2016

Infusion & transfusion, autologous

MHRA reference: 2016/004/019/701/003

Hologic: ThinPrep 5000 Processor with Autoloader

7 March 2016

IVDs, cytopathology & histopathology

Model: ASY-03098

MHRA reference: 2016/004/014/299/010

Hospira Plum A+ Infusion Pump, Plum 360 Infusion pump

13 April 2016

Infusion systems

MHRA reference: 2016/004/001/292/001

Intervene: Surety Introducer Needle 19G 38mm

8 April 2016

Injection devices

MHRA reference: 2016/004/014/299/005

Randox Laboratories: Magnesium on RX Daytona+ analyser

15 March 2016

IVDs, clinical chemistry

Model: MG8326

MHRA reference: 2016/004/015/601/003

Siemens: Artis one

29 January 2016

X Ray, fluoroscopy systems

Model: Artis one 10848600

MHRA reference: 2016/004/006/601/003

Smiths Medical: Medex ™ Cardiothoracic Custom sets

7 April 2016

Vascular cannula and catheters

MHRA reference: 2016/004/015/299/006

Völker : Völker-Bett 2080

C-0000275568

Beds and accessories

MHRA reference: 2015/011/019/291/010

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