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
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
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FSNs before this date are on the
Ortho Clinical Diagnostics: VITROS庐 Chemistry Product AMYL Slides Reagent
May 2020
IVDs, clinical chemistry
1202670 and 8112724
MHRA reference:
Smiths Medical: 3.0MM Hyperflex Tracheostomy Uncuffed, Adjust, Nec
18 May 2020
Airway devices
60HA30
MHRA reference:
Sooil Development: DANA Diabecare RS
SOOIL QA-200102-01
Infusion systems
MHRA reference:
Stryker: Restoration 庐Anatomic Shell
RA2020-2209440
Joint prosthesis, hip
MHRA reference:
Thermo Fisher Scientific: Optilite庐 Clinical Chemistry
18 May 2020
Clinical chemistry
MHRA reference:
Thermo Fisher Scientific: Oxoid
13 May 2020
IVDs bacteriology
DR0100M
MHRA reference:
Tosoh: Automated Enzyme Immunoassay Analyzer AIA-900
18 May 2020
IVDs, clinical chemistry
MHRA reference:
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:
Balt Extrusion: SPIF
21 May 2020
Embolisation coils
Model: SPIF 2,5X5P10 and SPIF 2,5X20P10
MHRA reference:
Beckman Coulter: Remisol Advance
12 May 2020
IVDs, haematology
Model: C37500 - DxH 600/800/900/690T Driver
MHRA reference:
Dr. J. H盲nsler GmbH: OZONOSAN Keimstop
3035.2020
Infusion & transfusion, administration sets
MHRA reference:
Fannin: MUELLER HINTON AGAR + 5% BLOOD & NAD (4mm) (EUCAST)
06 May 2020
IVDs, bcateriology
Model: W11171
MHRA reference:
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:
Updates to this page
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Added missing FSNs from the notice
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First published.