Field Safety Notice - 16 to 20 April 2018

Summary List of field safety notices (FSNs) from medical device manufacturers from 16 to 20 April 2018.

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 F SNs

Arrow International (Teleflex Medical)

12 April 2018

Vascular cannula and catheters

MHRA reference: 2018/004/013/478/010

BioFire Diagnostics: FilmArray Blood Culture Identification (BCID) Pan

03 March 2018

IVDs, bacteriology

MHRA reference: 2018/003/026/701/019

Chalice Medical: Paragon

16 January 2018

Infusion & transfusion, heart lung circuits

PMP Oxygenators

MHRA reference: 2018/001/030/601/003

Cook Medical: Soft-Trans Embryo Transfer Catheter

11 April 2018

Laboratory equipment associated with IVF, cells, tissues

MHRA reference: 2018/004/016/701/016

Covidien / Medtronic: EEA™ Hemorrhoid and Prolapse Stapler Set with DST Series™ Technology

April 2018

Staples and staple guns

Model: HEM3335, HEM3348

MHRA reference: 2018/004/016/291/004

Draeger Medical Systems: Jaundice Meter JM-103

March 2018

Diagnostic measurement and monitoring

MHRA reference: 2018/004/016/291/008

Draeger Medical Systems: Infinity Acute Care System (M540)

March 2018

Monitors, patient

MHRA reference: 2018/004/019/291/002

Draeger Medical Systems: Jaundice Meter JM-105

March 2018

Diagnostic measurement and monitoring

MHRA reference: 2018/004/017/291/014

GE Healthcare: Innova IGS620/630/520/530/540; Discovery IGS730/740

12266

X Ray, fluoroscopy systems

MHRA reference: 2018/004/016/478/003

IBL International: Progesterone Luminescence Immunoassay

17 April 2018

IVDs, clinical chemistry

MHRA reference: 2018/004/018/701/016

JRI Orthopaedics

16 April 2018

Joint prosthesis, hip

Aeon ref 0420012

MHRA reference: 2017/005/018/401/018

MRC-Holland: SALSA MLPA Probemix P060 SMA

02 April 2018

Instrumentation/ platform

MHRA reference: 2018/004/003/701/004

Randox Laboratories: RX Imola

06 April 2018

IVDs, clinical chemistry

RX4900, RX4900R

MHRA reference: 2018/004/017/601/005

Schiller: Cardiovit AT-102 plus

10 April 2018

ECG

MHRA reference: 2018/004/019/701/008

Thermofisher Scientific: Thermo Scientific™ Oxoid™ Brilliance™ Salmonella Agar Base, CM1092B&T

20 February 2018

IVDs, bacteriology

MHRA reference: 2018/003/020/601/003

Zimmer: Segmental System Proximal Femoral Component 38mm

13 April 2018

Joint prosthesis, hip

MHRA reference: 2018/004/016/478/001

Published 19 April 2018