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.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 30 October 2017
• Last updated: 23 November 2017 — See all updates

• Message type: Field safety notice
• Medical specialty: Anaesthetics, Cardiology, Care home staff, Cosmetic surgery and Critical care
  Show 12 more
  General practice, General surgery, Haematology and oncology, Infection prevention, Obstetrics and gynaecology, Ophthalmology, Orthopaedics, Pathology, Physiotherapy and occupational therapy, Radiology, Theatre practitioners, and Urology
• Issued: 30 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. 23 November 2017

   Added FSN for Xograph

2. 30 October 2017

   First published.