Field Safety Notice: 24 to 28 June 2019

List of field safety notices (FSNs) from medical device manufacturers from 24 to 28 June 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

Becton Dickinson: BD Microtainer® K2E Tubes

PAS-19-1526

IVDs, specimen receptacles

MHRA reference: 2019/006/004/291/001

Biomet: Comprehensive Reverse Shoulder Inst Outer Case

24 June 2019

Surgical devices, non-powered

MHRA reference: 2019/006/024/487/015

Critical Diagnostics: Presage ST2 Assay

FSCA 19-002

IVDs, clinical chemistry

Model: BC-1065E

MHRA reference: 2019/006/024/228/004

Drive Devilbiss: SAMSOFT 175 - MINI SAMSOFT 150 - SAMSOFT+ - MINI SAMSOFT+

15 January 2019

Hoists and slings

MHRA reference: 2019/005/015/601/006

Elekta Ltd: HexaPOD evo RT System

June 2019

Radiotherapy

Model: P10603-109, P10603-110 and P10603-111

MHRA reference: 2019/006/024/701/019

Elitech Group: STI PLUS ELITe MGB Kit

19 June 2019

IVDs, bacteriology

MHRA reference: 2019/006/020/701/011

Fast Track Diagnostics: FTD ACE

June 2019

IVDs, clinical chemistry

MHRA reference: 2019/006/024/487/016

Fast Track Diagnostics FSN-FA-2019-05: FTD Neuro 9

June 2019

IVDs, viral microbiology

MHRA reference: 2019/006/025/487/001

GBUK Group (Enteral): Nutricare Infant Feeding Tube

26 June 2019

Feeding systems and tube

Model: NCI06.050ISOSAF-ROW

MHRA reference: 2019/006/026/601/005

GE Healthcare: ECG trunk cables, ECG Leadwires

39001-ROW

ECG

MHRA reference: 2019/006/027/701/006

Immundiagnostik AG

13 June 2019

IVDs, clinical chemistry

MHRA reference: 2019/006/021/487/004

KeyMed (Olympus): Nurses Control Panel Arm - Long

21 June 2019

Endoscopes, televisual systems

Model: Nurses Control Panel Arm - Long - MAJ-1664

MHRA reference: 2019/006/021/701/007

NuVasive: MAGEC Spinal Bracing and Distraction System

25 June 2019

Spinal implants

MHRA reference: 2019/006/027/487/006

Roche: MYO2 (Tina-quant Myoglobin Gen.2)

June 2019

IVDs, clinical chemistry

MHRA reference: 2019/006/020/701/008

Teleflex: Various

25 June 2019

Vascular cannula and catheters

MHRA reference: 2019/006/025/701/027

Published 4 July 2019