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
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: 2017/005/004/291/003
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