Field Safety Notice - 23 to 27 October 2017

Summary List of field safety notices (FSNs) from medical device manufacturers from 23 to 27 October 2017.

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

3M: 3M™ Bair Hugger™ Temperature Monitoring Sensor

19 October 2017

Diagnostic measurement and monitoring

MHRA reference: 2017/010/023/291/041

A&E Medical Corporation: MYO/Punch, A&E Surgical Punch

20 October 2017

Surgical instruments, articulated cutting

Model: 080-271, 080-351, 080-401, 080-403, 080-451, 080-481, 080-501

MHRA reference: 2017/010/026/291/005

Aesculap: COLUMBUS REV FEMUR SPACER DISTAL F5 15MM

24 October 2017

Joint prosthesis, knee

MHRA reference: 2017/010/025/701/031

Biomet

24 October 2017

Joint prosthesis, shoulder

Model: Comprehensive Reverse Versa-Dial Glenosphere Provisional Instruments and Comprehensive Humeral Head Provisional Instrument

MHRA reference: 2017/010/025/000/004

HOYA: PENTAX Endscopes (multiple types)

October 2017

Endoscopes, flexible

Model: EB-1170K, EB-1570, EB-1570AK, EB-1570K, EB-1970

MHRA reference: 2017/010/023/291/031

Hamamatsu Photonics: NanoZoomer-SQ

25 October 2017

IVDs, cytopathology & histopathology

Model: C13140-21

MHRA reference: 2017/010/026/000/003

Integrum AB: Abutment Screw Diamond

19 October 2017

Osteosynthesis, bone screws

Model: Abutment Screw Diamond 1191, 1192

MHRA reference: 2017/010/023/291/054

Liko AB: Carraige S65 W Single Hook

MOD1267

Hoists and slings

Model: 3036011

MHRA reference: 2017/010 /012/291/013

LivaNova: PERFUSION TUBING SYSTEMS

05 October 2017

Infusion & transfusion, heart lung circuits

MHRA reference: 2017/010/011/291/008

Maxter Catheters: Nasogastric Feeding Tubes for neonates & pediatric

17 October 2017

Feeding systems and tubes

Model: 503xx 503Txx 503TLXX 505xx 506XX 507xx 507LXX 508xx

MHRA reference: 2017/010/023/701/012

Sysmex: FLUOROCELL PLT

28 August 2017

IVDs, haematology

MHRA reference: 2017/009/019/291/001

Thermo Fisher Scientific: enGen Laboratory Automation & Automation solutions

8 September 2016

IVDs, clinical chemistry

MHRA reference: 2016/009/012/601/002

Thermofisher Scientific: Oxoid Mueller-Hinton Agar Broth

19 October 2017

IVDs, bacteriology

Model: CM0405B

MHRA reference: 2017/010/020/601/004

Xograph Healthcare: Airway Bougie

12 June 2017

Airway devices

MHRA reference: 2017/006/006/291/036

Published 30 October 2017
Last updated 23 November 2017 + show all updates
  1. Added FSN for Xograph
  2. First published.