Field Safety Notices - 25 February 2019 - 1 March 2019

List of field safety notices (FSNs) from medical device manufacturers from 25 February 2019 - 1 March 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

ArthroCare (Smith & Nephew): SmartStitch PerfectPasser Connecto

26 February 2019

Sutures

MHRA reference: 2019/002/028/487/032

Brainlab: Spine & Trauma 3D Navigation 1.0

11 February 2019

Surgical navigation system and accessories

22268C. the model numbers are listed in Material column on customer list attachment

MHRA reference: 2019/002/025/701/017

Cook: Inferior Vena Cava (IVC) Filter

25 February 2019

Implants, non-active, vena cava filters

MHRA reference: 2019/002/025/291/004

Etac: Molift 2-point Sling Bar- All sizes

26 February 2019

Hoists and slings

430016, 1430017, 1430021, 1830001, 183002, 183002C, 1830003

MHRA reference: 2019/002/028/487/035

Fast Track Diagnostics: FTD Fever and rash

February 2019

IVDs, viral microbiology

MHRA reference: 2019/002/022/701/024

GE: ECG trunk cable

GEHC Ref# 39000

Infusion & transfusion, heart lung circuits

ECG

ECG trunk cable 2106309-001, 2106309-002

MHRA reference: 2019/002/022/701/008

Hamilton: HAMILTON-G5/S1 ventilator unit

11 February 2019

Lung ventilators

MHRA reference: 2019/002/027/291/004

Hamilton: HAMILTON-G5/S1 ventilator unit

11 February 2019

Lung ventilators

MHRA reference: 2019/002/027/291/004

IHSS: SYNTHES CODMAN MATRIX

27 February 2019

Osteosynthesis, bone plates

SYNTHES CODMAN MATRIX

MHRA reference: 2019/002/027/291/020

Luminex: ARIES products, see attached FSN

19 February 2019

IVDs, bacteriology

PN 50-10017, PN 50-10031, PN 50-10037, PN 50-10020, PN

MHRA reference: 2019/002/028/487/026

Luminex: xTAG® Gastrointestinal Pathogen Panel (GPP)

February 2019

IVDs, viral microbiology I032C0324

MHRA reference: 2019/002/020/291/005

Medacta International: GMK UNI Femur Sizes 3 & 4

22 February 2019

Joint prosthesis, knee

MHRA reference: 2019/002/028/487/031

MEIKA Group: Lipocell

01 February 2019

Dermal substitutes, tissue scaffolds

MHRA reference: 2019/002/028/487/030

Ortho-Clinical: VITROS 3600, 5600, XT7600, ECi, ECiQ

February 2019

IVDs, clinical chemistry

MHRA reference: 2019/002/026/601/500

Radiometer: TCM5 FLEX/TCM5 BASIC

FAN 915-375 Diagnostic measurement and monitoring

MHRA reference: 2017/010/012/291/008

Randox Laboratories: Urinalysis Control Level 2

22 February 2019

IVDs, clinical chemistry

Urinalysis Control Level 2 UC5034

MHRA reference: 2019/002/022/601/015

Regen Lab: RegenKit-BCT-3T, RegenKit-BCT-2A, RegenKit-BCT-4

06 February 2019

Storage & collection devices

MHRA reference: 2019/002/011/487/002

TERUMO: LifePearl® microspheres

February 2019

Implants, non-active, embolisation products

8LP2S200

MHRA reference: 2019/002/026/291/011

Vyaire Medical: enFlow

FSCA 19-001

Blood/Fluid Warming Systems

MHRA reference: 2019/001/004/302/001

Published 4 March 2019
Last updated 8 March 2019 + show all updates
  1. Added FSCA for Vyaire Medical: enFlow
  2. First published.