Field Safety Notice: 30 September to 04 October
List of field safety notices (FSNs) from medical device manufacturers from 30 September to 04 October
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: PI FREESTYLE OPTIUM T/STRIPS 50
20 September 2019
IVDs, self / home testing
MHRA reference: 2019/009/013/228/013
Baxter: TherMax Blood Warmer Unit, ROW
October 2019
Blood/fluid warming systems
MHRA reference: 2019/010/003/228/001
Brainlab: Patient Data Manager (PDM)
CAPA-20190904-002337
Infusion systems
Please refer to “8 Comments” for model numbers
MHRA reference: 2019/009/030/701/006
Fast Track Diagnostics
September 2019
IVDs, viral microbiology
MHRA reference: 2019/009/027/487/018
Medoderm: LQD
30 September 2019
Basic dressings, absorbents, swabs, procedure packs
PZN-13833368; PZN-13833380; PZN-13833397 (only in Germany)
MHRA reference: 2019/010/001/601/003
Medtronic: Various
October 2019
Implants, active, defibrillators
Model: Various (please see FSN)
MHRA reference: 2019/010/003/487/013
Philips: V680 Ventilators
22 August 2019
Lung ventilators
V680 Ventilators
MHRA reference: 2019/009/023/487/038
Randox: Liquid Cardiac Controls
01 October 2019
IVDs, clinical chemistry
CQ5051, CQ5052, CQ5053
MHRA reference: 2019/010/002/601/002
Roche: Cardiac Pipettes
September 2019
IVDs, clinical chemistry
MHRA reference: 2019/010/001/701/026
Siemens: Atellica CH 930 Analyzer
September 2019
IVDs, clinical chemistry
Atellica CH 930 Analyzer
MHRA reference: 2019/009/026/601/003
Siemens: Atellica UAS 800 Analyzer
September 2019
IVDs, clinical chemistry
MHRA reference: 2019/009/030/601/005
Teleflex: EZ-IO 15MM needle + stabilizer BX/5 (EE)
03 October 2019
Injection devices
MHRA reference: 2019/010/003/487/012
Terumo: Terumo Hypodermic NEOLUS Needle
September 2019
Injection devices
Terumo Hypodermic NEOLUS Needle
MHRA reference: 2019/009/027/487/024
Vygon: V-Green Narrow Bore+Clamp IV Extension Line
03 October 2019
Infusion & transfusion, administration sets
6222.051, 6222.071, 6222.151, 6222.201
MHRA reference: 2019/010/003/601/003