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
Cellnovo: Cellnovo Insulin Infusion System 鈥� Bolus Dose Calculator
28 December 2018
Infusion systems
MHRA reference:
Convatec: Suction Catheters, Gastro-enteral Tubes
04 January 2019
Suction equipment
MHRA reference:
Edwards: Swan Ganz Thermodilution Catheter
FCA 122
Vascular cannula and catheters
MHRA reference:
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:
Flexicare: Laryseal Flexi Laryngeal Mask
07 January 2019
Airway devices
MHRA reference:
Intuitive Surgical: da Vinci庐 Harmonic ACE Insert
ISIFA2018-21-R Endoscopes, rigid Model: 400272
MHRA reference:
Smith & Nephew: PLUS, SL MIA DBL OFFSET ADAPT. RT 60/25MM
07 January 2019
Orthopaedic surgical instruments - insertion/extraction tools
MHRA reference:
ThermoFisher (Scientific): Oxoid Brilliance鈩� Clarity UTI / /Staph Strep CNA (mod) Biplate
03 January 2019
IVDs, bacteriology
MHRA reference:
ThermoFisher Scientific: Oxoid BHI Broth + Horse Serum
03 January 2019
IVDs, bacteriology
MHRA reference:
Thermo Scientific: Oxoid Meropenem M.I.C.E. Strips
21 December 2018
IVDs, bacteriology
MHRA reference:
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:
Updates to this page
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Added Topcon DRI to list
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First published.