Field Safety Notice: 12 to 16 August 2019

List of field safety notices (FSNs) from medical device manufacturers from 12 to 16 August 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

Arjo: Concerto / Basic Shower Trolley

12 August 2019

Trolleys and chairs

BAB1000-01, BAB1000CON6102, BAB1007-01, BAB1101-01,

MHRA reference: 2019/008/009/601/007

Biomatrica: LBgard Blood Collection Tube

08 August 2019

Storage & collection devices

CE-71001-002

MHRA reference: 2019/008/009/701/007

BioPro

26 June 2019

Central sterilisation services materials

MHRA reference: 2019/006/028/701/010

Breas Medical: NIPPY 22mm Breathing circuits

07 August 2019

Breathing system components

0792/Sp1, 0793/SP1, 0794/SP7, 0791/SP7v1, 0794/SP10, 0805/

MHRA reference: 2019/008/009/487/010

Fresenius: NaCl 0,9% Fresenius CFX DUO 3000ml

17 June 2019

Infusion & transfusion, administration sets

F1335161 / F1339161

MHRA reference: 2019/006/014/601/009

Gambro - Baxter: Prismaflex System, Prismaflex 4.11, Prismaflex 5.00 Row, Prismaflex 6.10

Row, Prismaflex 7.XX Row

August 2019

Dialysis, haemodialysis

Machine Haemodialysis: 114870, 113874, 107493, 114489, 113082

MHRA reference: 2019/008/013/487/036

Gentherm Medical: Norm-O-Temp 111W

14 August 2019

Heating, patient, electrical pads & blankets

Norm-O-Temp 111W

MHRA reference: 2019/008/006/487/010

Medineering: Surgical Base System

09 August 2019

Operating table

Surgical Base System SBS 1.3

MHRA reference: 2019/008/009/701/028

Medtronic: Micra Transcatheter Leadless Pacemaker system

August 2019

Implants, active, intracardiac (leadless)

MC1VR01

MHRA reference: 2019/008/013/487/035

Nihon Kohden: CSM-1500 and CSM-1700

August 2019

Monitors, Patient

Model: CSM-1500 and CSM-1700

MHRA reference: 2019/008/015/487/007

Radiometer: AQURE system

FAN 915-398

IVDs, extra laboratory testing

933-599

MHRA reference: 2019/007/019/701/004

Siemens: Atellica CH 930 Analyzer

July 2019

IVDs, clinical chemistry

Atellica CH 930 Analyzer

MHRA reference: 2019/008/012/601/006

Thermo Fisher: Oxoid

08 August 2019

IVDs, bacteriology

MA0121D/F

MHRA reference: 2019/008/008/601/004

Published 19 August 2019
Last updated 27 August 2019 + show all updates
  1. List of field safety notices (FSNs) from medical device manufacturers from 12 to 16 August 2019.
  2. First published.