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

Updates to this page

Published 2 March 2020