Field Safety Notice - 31 July to 4 August 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 31 July to 4 August 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
Beckman Coulter: PrepPlus 2 an PrepPlus Sample Preparation Systems
31 July 2017
IVDs, haematology
MHRA reference: 2017/006/002/601/003
Becton Dickinson: BD MAX Vaginal Panel & UVE Specimen Collection kit
19 July 2017
IVDs, bacteriology
MHRA reference: 2017/007/024/701/003
Boston Scientific: EMBLEM™ S-ICD Programmer
March 2017
Implants, active, defibrillators
Model: 3200
MHRA reference: 2017/001/010/299/013
Cell Marque: Protease Digestive Enzyme
29 July 2017
IVDs, cytopathology & histopathology
MHRA reference: 2017/007/006/601/011
Edwards: Fogarty Adherent Clot Catheter
July 2017
Vascular cannula and catheters
Model: 1408010 and 140806
MHRA reference: 2017/008/001/701/003
In2Bones SAS: NEO Non-Locking screw / NEOVIEW screw set
13 July 2017
Osteosynthesis, bone screws
Model: W27 ST010, W27 ST014, W24 ST014, W27 ST016, W27 ST018, W27 ST900
MHRA reference: 2017/007/014/291/019
Maquet: PLEGIOX Cardioplegic Heat Exchanger
26 July 2017
Infusion & transfusion, heart lung circuits
Model: 70103.4981, 70103.2522, 70103.6144
MHRA reference: 2017/008/002/291/015
Oscor: ATAR™ EXTENSION CABLES
3 July 2017
Implants, active, pacing leads, temporary
Model: See Attachment A and B
MHRA reference: 2017/008/001/701/019
Smiths Medical: Medfusion® Model 3500; Medfusion® Model 4000
August 2017
Infusion systems
Model: 880.5725 Infusion Pump
MHRA reference: 2017/006/029/291/008
Zimmer: Guide wire 70 cm
19 June 2017
Orthopaedic surgical instruments –measuring tools
MHRA reference: 2017/006/020/291/001
Zimmer Biomet: ROSA
28 July 2017
Surgical navigation system
Model: ROSA 2.5.8
MHRA reference: 2017/008/001/291/018