Field Safety Notice - 1 May to 5 May 2017

Summary List of field safety notices (FSNs) from medical device manufacturers from 1 May - 5 May 2017

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: ARCHITECT Free T4 Reagent Kit

28 April 2017

IVDs, clinical chemistry

MHRA reference: 2017/005/002/701/047

Biomet: 8mm Bone Dowel Harvest Tube

21 April 2017

Surgical instruments, non-articulated cutting

MHRA reference: 2017/005/004/701/024

Cardinal Health: Jackson - Pratt Drain

21 April 2017

Wound drains

MHRA reference: 2017/004/028/601/010

Dexcom: G4 PLATINUM and GS Mobile receiver

April 2017

Continuous glucose monitoring systems (CGMS)

Model: MT20649-1, MT20649-2, MT22719-1, MT22719-2

MHRA reference: 2016/002/025/291/005

Diagnostica Stago: ASSERACHROM VWF:CB

April/May 2017

Coagulation

MHRA reference: 2017/005/003/291/017

IBA Dosimetry: Stealth Chamber

21 April 2017

Radiotherapy

Model: DS50-001-XL-T, DS50-002-XL-T, DS50-003-XL-T, DS50-102-XL-T, DS50-103-XL-T,

MHRA reference: 2017/004/028/601/005

Medtronic: Pedicle Access Kit (PAK) Needles

May 2017

Orthopaedic surgical instruments

Model: 8670009

MHRA reference: 2017/005/004/291/0030

Mölnlycke: Brennen® Skin Graft Mesher

27 April 2017

Surgical power tools

Model: See attached Product Table

MHRA reference: 2017/004/028/701/021

Ortho Clinical Diagnostics: ORTHO Workstation

04 May 2017

IVDs, blood transfusion

MHRA reference: 2017/005/003/601/008

Stealth Products: ULTRA SUB-OCCIPITAL PAD, SMALL, MEDIUM

13 April 2017

Wheelchairs, accessories

Model: 610 & 600, ULTRA SUB-OCCIPITAL PAD, SMALL, MEDIUM

MHRA reference: 2017/004/019/701/016

Published 8 May 2017