Field Safety Notice: 7-11 January 2019

List of field safety notices (FSNs) from medical device manufacturers from 7 to 11 January 2019

• From: Medicines and Healthcare products Regulatory Agency
• Published: 14 January 2019
• Last updated: 8 February 2019 — See all updates

• Message type: Field safety notice
• Issued: 14 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

Published 14 January 2019
Last updated 8 February 2019 + show all updates

1. 8 February 2019

   Added Topcon DRI to list

2. 14 January 2019

   First published.