Field Safety Notices - 24 to 28 February 2020
Summary List of field safety notices (FSNs) from medical device manufacturers from 24 to 28 February 2020
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
Argon Medical: WORKER™ Amplatz Guidewires
9 December 2019
Vascular cannula/catheter accessories
114135080, 114135150
MHRA reference:2020/002/026/701/072
BHL-Medical: Transset Duo Syringe
18 February 2020
Media injectors
PR-20198
MHRA reference: 2020/002/025/291/001
Biocartis: Idylla™ EGFR Mutation Test
20 February 2020
IVD, genetic testing
MHRA reference: 2020/002/026/291/001
CAIR: STOPCOCK WITH MOBILE RING
27 January 2020
Infusion & transfusion, connectors
MHRA reference: 2020/002/025/291/002
EV3- Medtronic: PipelineTM Flex Embolization Device (with Shield TechnologyTM)
February 2020
Intracranial Flow diverters / stents
PED-250-XX, PED-275-XX, PED-300-XX, PED-325-XX, PED-350-XX, PED-375-XX, PED-400-XX, PED-425-XX, PED-450-XX, PED-475-XX, PED-500-XX, PED2-250-XX, PED2-275-XX, PED2-300-XX, PED2-325-XX, PED2-350-XX, PED2-375-XX, PED2-400-XX, PED2-425-XX, PED2-450-XX, PED2-475-XX, PED2-500-XX
MHRA reference: 2020/002/026/291/003
GS Elektromed. Geraete G. Stemple: corpuls3
10 February 2020
Defibrillators, non-implantable
Model: 04100, 04100.1, 04100.2, 04200, 04200.1, 04200.2, 04300
MHRA reference: 2020/002/020/291/011
INNOTERE: INNOTERE Paste-CPC
15 January 2020
Bone cement and tools
MHRA reference: 2020/002/021/291/003
Insulet Corporation: Omnipod DASH Insulin Management System
20 February 2020
Infusion systems
PT-000010 and PT-000011
MHRA reference: 2020/002/013/291/011
Leckey: MyWay Harness
25 February 2020
Walking aids, rollators
MHRA reference: 2020/002/024/601/003
Luminex: VERIGENE® Reader
06 December 2019
IVDs, bacteriology
MHRA reference: 2020/002/021/291/004
NuVasive: MAGEC® Spinal Bracing and Distraction System
13 February 2020
Spinal implants
MAGEC System Model X
MHRA reference: 2020/002/018/291/002
Philips: 865457: G50 (China), 865459: G60 (China),865486: G60 (Int’l), 866079: G70 (China), 866080: G80 (China), 866081: G70 (Int’l), 866082: G80 (Int’l)
February 2020
Monitors, patient
MHRA reference: 2020/002/026/291/002
Radiometer: ABL800 analyzers
21 February 2020
IVDs, extra laboratory testing 393-800/393-801
MHRA reference: 2020/002/025/291/004
Siemens: Direct Bilirubin and Total Bilirubin Assays
February 2020
IVDs, clinical chemistry
MHRA reference: 2020/002/025/601/011
Siemens: CLINITEK Status +Analyzer
January 2020
IVDs, clinical chemistry
MHRA reference: 2020/002/025/291/003
SOMNOmedics: LIC2/EC2+
26 February 2020
Barrier creams & sprays
MHRA reference: 2020/002/026/291/005
Zimmer- Biomet: Comprehensive Shoulder Mini Humeral Stem
25 February 2020
Joint prosthesis, shoulder
MHRA reference: 2020/002/025/291/005