Field Safety Notices: 07 December to 11 December 2020

List of field safety notices (FSNs) from medical device manufacturers from 07 December to 11 December 2020

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

View a list of FSNs published since January 2020

View FSNs since November 2014. FSNs before this date are on the National Archives website

Beckman Coulter: Access Unconjugated Estriol(Update to FSN wk 14 – 18 September 2020)

26 November 2020

IVDs, clinical chemistry

Model: Not applicable

MHRA reference: 2020/009/016/601/001

Becton Dickinson: BD Regional Block Needle

09 December 2020

Injection devices

MHRA reference: 2020/012/004/291/006

GE: Carestation 600 Series

07 December 2020

Anaesthetic machines & monitors

MHRA reference: 2020/012/007/291/005

GS Elektromed: corpuls3

01 December 2020

Defibrillators, non implantable

Model: 04301

MHRA reference: 2020/012/010/487/007

Hamilton Medical: HAMILTON-H900 Humidifier

04 December 2020

Humidifiers

MHRA reference: 2020/012/007/487/003

Helena BioSciences: K-ACT Actalyke Clotting Test Tubes

20 November 2020

Coagulation

MHRA reference: 2020/011/023/487/003

IM Med: iM CleanStage Two

01 December 2020

Disinfectants for medical devices

Model: 110205

MHRA reference: 2020/012/009/601/004

MAR-MED: Tourni-Cot Universal

04 December 2020 Surgical equipment, tourniquets Model: Tourni-Cot Universal - TCU - 6001 MHRA reference: 2020/012/007/291/002

December 2020

Software as a medical device (SaMD)

MHRA reference: 2020/012/009/487/008

Siemens: Chemistry Calibrator (Update to FSN wk 15 – 19 June 2020)

August 2020 IVDs, clinical chemistry MHRA reference: 2020/006/012/601/001

Siemens Healthcare: Atellica IM 1300/1600 and CH 930 Analyzers

November 2020

IVDs, clinical chemistry

MHRA reference: 2020/012/009/601/007

SIS MEDICAL: OPN NC PTCA Dilatation Catheter

October 2020

Vascular cannula and catheters

MHRA reference: 2020/011/006/601/004

Smiths Medical: Portex Loss Of Resistance Device

03 December 2020

Injection devices

Model: 100/398/000

MHRA reference: 2020/012/007/291/003

Updates to this page

Published 14 December 2020