Field Safety Notice: 7-11 January 2019
List of field safety notices (FSNs) from medical device manufacturers from 7 to 11 January 2019
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
Cellnovo: Cellnovo Insulin Infusion System – Bolus Dose Calculator
28 December 2018
Infusion systems
MHRA reference: 2018/012/031/291/004
Convatec: Suction Catheters, Gastro-enteral Tubes
04 January 2019
Suction equipment
MHRA reference: 2018/007/009/291/014
Edwards: Swan Ganz Thermodilution Catheter
FCA 122
Vascular cannula and catheters
MHRA reference: 2019/001/008/291/008
Endologix:Nellix, Endovascular Aneurysm Sealing System N10-100, N10-110, N10-120, N10-130, N10-140, N10-150, N10-160, N10-170, N10-180, N10-190, N10-200, NP-002; NP-004; NP-001; NP-003; NP-005; NX-001, NX-002a
04 January 2019
Implants, non active, endoprostheses for aortic aneurysms
MHRA reference: 2019/001/004/601/004
Flexicare: Laryseal Flexi Laryngeal Mask
07 January 2019
Airway devices
MHRA reference: 2018/012/014/487/008
Intuitive Surgical: da Vinci® Harmonic ACE Insert
ISIFA2018-21-R Endoscopes, rigid Model: 400272
MHRA reference: 2019/001/004/487/006
Smith & Nephew: PLUS, SL MIA DBL OFFSET ADAPT. RT 60/25MM
07 January 2019
Orthopaedic surgical instruments - insertion/extraction tools
MHRA reference: 2019/001/009/291/009
ThermoFisher (Scientific): Oxoid Brilliance™ Clarity UTI / /Staph Strep CNA (mod) Biplate
03 January 2019
IVDs, bacteriology
MHRA reference: 2019/001/003/601/009
ThermoFisher Scientific: Oxoid BHI Broth + Horse Serum
03 January 2019
IVDs, bacteriology
MHRA reference: 2019/001/007/601/006
Thermo Scientific: Oxoid Meropenem M.I.C.E. Strips
21 December 2018
IVDs, bacteriology
MHRA reference: 2019/001/003/601/008
Topcon: 3D OPTICAL COHERENCE TOMOGRAPHY DRI OCT Triton
10 January 2019
Optical, ophthalmic instruments & equipment
Model: DRI OCT Triton, DRI OCT Triton plus
MHRA reference: 2019/001/010/487/012
Last updated 8 February 2019 + show all updates
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Added Topcon DRI to list
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First published.