Field Safety Notices: 7 to 10 May 2019

List of field safety notices (FSNs) from medical device manufacturers from 7 to 10 May 2019.


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

Abbott: ARCHITECT c4000 / c8000 / c16000 Mixer

01 May 2019

IVDs, clinical chemistry

MHRA reference: 2019/005/003/701/020

Biomet (Zimmer): Femoral Drill Guide

8 May 2019

Orthopaedic surgical instruments - measuring tools femoral drill guide

MHRA reference: 2019/005/008/487/006

Beckman: Access Free T4' Access Free T3, Access Total T3, Access Thyroglobulin, Access GI Monitor, Access Thyroglobulin Antibody II

03 May 2019

IVDs, clinical chemistry

MHRA reference: 2019/005/003/601/008

CardinalHealth: Monoject™ needles and cannulas

01 May 2019

Injection devices

MHRA reference: 2019/005/002/291/003

CardinalHealth - Medtronic: Mahurkar™ Triple Lumen Catheter; Mahurkar™ Dual Lumen Catheter; Argyle™ Single Lumen Catheter

May 2019

Vascular cannula and catheters

MHRA reference: 2019/005/007/487/003

Carestream: Carestream Health

03 May 2019

Computed tomography

OnSight 3D Extremity System

MHRA reference: 2019/005/007/487/001

Medical Service - Teleflex: Mobile SL, Ch 12, 40 cm, Ergothan/Mobile SL, Ch 14, 40 cm, Ergothan/ Mobile SL, Ch 14, 20 cm, Ergothan

09 May 2019

Urinary catheters and accessories

MHRA reference: 2019/005/009/701/006

Omixon Biocomputing

07 May 2019

IVDs, immunology

MHRA reference: 2019/005/007/291/003

Philips: Philips SureSigns VS Monitors

April 2019

Monitors, patient

MHRA reference: 2019/005/007/291/002


06 May 2019

IVD, genetic testing RNeasy DSP FFPE Kit

MHRA reference: 2019/005/009/701/001

Randox: G-6-PDH Control Deficient and Normal

01 May 2019

IVDs, clinical chemistry

Model: PD2617, PD2618

MHRA reference: 2019/003/027/601/003

Redcord: Redcord Axis

29 April 2019

Therapy, traction 110050

MHRA reference: 2019/005/009/487/001

SenoRx: EnCor® Breast Biopsy Probe

01 May 2019


Model: ECP0110G, ECP017G, ECP0110GV, ECP017GV, ECP0112G, ECP0112GV

MHRA reference: 2019/005/001/291/010

Strathclyde Pharmaceuticals- Munro Group: Brand

07 May 2019

IVDs, self / home testing

Accu-Chek Active test strips

MHRA reference: 2019/004/025/291/001

Terumo: SOLOPATH® Expandable, SOLOPATH® Re-collapsible

May 2019

Vascular cannula/catheter accessories

MHRA reference: 2019/005/007/487/018

Una Health: VTRUST TD-4258

18 January 2019

IVDs, self / home testing

Model: TD-4258

MHRA reference: 2018/009/011/401/508

Published 13 May 2019