Field Safety Notices - 18 to 22 May 2020

Summary list of field safety notices (FSNs) from medical device manufacturers from 18 to 22 May 2020

From:
Medicines and Healthcare products Regulatory Agency
Published
26 May 2020
Last updated
29 May 2020 — See all updates
Message type:
Field safety notice
Issued:
26 May 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

View a list of FSNs published since January 2020

View FSNs since November 2014

FSNs before this date are on the National Archives website

Ortho Clinical Diagnostics: VITROS® Chemistry Product AMYL Slides Reagent

May 2020

IVDs, clinical chemistry

1202670 and 8112724

MHRA reference:2020/005/013/601/012

Smiths Medical: 3.0MM Hyperflex Tracheostomy Uncuffed, Adjust, Nec

18 May 2020

Airway devices

60HA30

MHRA reference: 2020/005/021/487/003

Sooil Development: DANA Diabecare RS

SOOIL QA-200102-01

Infusion systems

MHRA reference: 2020/002/014/291/006

Stryker: Restoration ®Anatomic Shell

RA2020-2209440

Joint prosthesis, hip

MHRA reference: 2020/004/027/487/003

Thermo Fisher Scientific: Optilite® Clinical Chemistry

18 May 2020

Clinical chemistry

MHRA reference: 2020/005/019/291/011

Thermo Fisher Scientific: Oxoid

13 May 2020

IVDs bacteriology

DR0100M

MHRA reference: 2020/005/018/601/001

Tosoh: Automated Enzyme Immunoassay Analyzer AIA-900

18 May 2020

IVDs, clinical chemistry

MHRA reference: 2020/005/015/487/003

Zimmer: Anaverse Glenoid Liner (XS, S, M, L)

19 May 2020

Joint prosthesis, shoulder

01.04440.011; 01.04440.012;01.04440.013;01.04440.014;

MHRA reference: 2020/005/019/291/006

Balt Extrusion: SPIF

21 May 2020

Embolisation coils

Model: SPIF 2,5X5P10 and SPIF 2,5X20P10

MHRA reference: 2020/005/021/487/010

Beckman Coulter: Remisol Advance

12 May 2020

IVDs, haematology

Model: C37500 - DxH 600/800/900/690T Driver

MHRA reference: 2020/005/014/601/004

Dr. J. Hänsler GmbH: OZONOSAN Keimstop

3035.2020

Infusion & transfusion, administration sets

MHRA reference: 2020/004/030/487/001

Fannin: MUELLER HINTON AGAR + 5% BLOOD & NAD (4mm) (EUCAST)

06 May 2020

IVDs, bcateriology

Model: W11171

MHRA reference: 2020/005/021/601/001

Gambro Dasco (Baxter): ARTISET HD SN HC, ULTRA HDF LINE, ARTISET HD DNL HC, ARTISET PREPOST

07 May 2020

Dialysis, blood lines

Produce codes: 114533, 115283, 955075, 955077

MHRA reference: 2020/005/005/487/009

Published 26 May 2020
Last updated 29 May 2020 + show all updates

  1. Added missing FSNs from the notice

  2. First published.