Field Safety Notices - 22 - 26 August 2016

Summary List of field safety notices (FSNs) from medical device manufacturers from 22 - 26 August 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

Beckman Coulter: UniCel DxH 800/600 Cellular Analysis Systems

17 August 2016

IVDs, haematology

MHRA reference: 2016/008/018/601/002

BIOMET: OPTIPAC 40 & 60 REFOBACIN BONE CEMENT R

17 August 2016

Bone cement and tools

MHRA reference: 2016/008/022/701/007

Focus Diagnostics: Simplexa™ Flu A/B & RSV Direct, Integrated Cycler

6 May 2016

IVDs, viral microbiology

MHRA reference: 2016/008/018/299/014

JRI Orthopaedics: AEON Hip System

22 August 2016

Joint prosthesis, hip

Model: AEON Hip System Stems: 0510005, 0510015, Cups: 0341240, 0341242

MHRA reference: 2016/008/019/291/008

Medicrea International: Medicrea International

A08100200

Spinal implants

MHRA reference: 2016/006/001/299/014

Nalge Nunc International: Linear Barcoded Tubes - Cryogenic specimen container IVD, sterile

9 August 2016

IVDs, cytopathology & histopathology

MHRA reference: 2016/008/023/299/013

Ortho-Clinical: VITROS GLU; LAC: TRIG & URIC Slides

12 August 2016

IVDs, clinical chemistry

MHRA reference: 2016/008/018/601/008

Panthera: Panthera S3, Panthera S3 short, Panthera U3

16 June 2016

Wheelchairs, manual

Model: 548XX00BLG, 548XX00BLG, 548XX00BLG

MHRA reference: 2016/007/027/299/016

Pennine Ryles Tube - Various

23 August 2016

Feeding systems and tubes

MHRA reference: 2016/008/024/291/001

Sage Products: Comfort Shield® Barrier Cream Cloths

23 August 2016

Barrier creams & sprays

Model: 7526-X (24-pk), 7453-X (3-pk), 7905-X (8-pk)

MHRA reference: 2016/008/025/291/006

Siemens: RAPIDPoint®

August 2016

IVDs, extra laboratory testing

MHRA reference: 2016/008/018/601/009

Siemens: Dimension® and Dimension Vista® AADVIA® Chemistry Systems, Syva®

19 August 2016

IVDs, clinical chemistry

MHRA reference: 2016/008/023/601/002

Sorin Group: PLATINIUM

August 2016

Implants, active, defibrillators

Model: PLATINIUM VR 1210, VR 1240, DR 1510, DR 1540, CRT-D 1711, CRT-D 1741, SONR CRT-D 1811, SONR CRT-D 1841

MHRA reference: 2016/008/023/299/011

Stryker: Cup Positioner / Impactor Handle Assembly

18 August 2016

Orthopaedic surgical instruments - Impacting tools

Model: 2101-0200

MHRA reference: 2016/008/025/291/021

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