Field Safety Notices - 01 to 05 June 2020

Summary list of field safety notices (FSNs) from medical device manufacturers from 01 to 05 May 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

Abbott: TactiCathTM Quartz Contact Force Ablation Catheter

28 May 2020

Therapy tissue ablation

Model: Model PN-004 065 and PN-004 075

MHRA reference: 2020/005/028/487/006

Boston Scientific: IceFORCE & IcePearl 2.1 CX Cryoablation Needles

92552660-FA

Surgical, cryogenic

MHRA reference: 2020/006/004/291/003

Cook Medical: Zenith Alpha® Abdominal Endovascular Graft

27 May 2020

Implants, non active, endoprostheses for aortic aneurysms

MHRA reference: 2020/006/003/291/004

KCI Medical: ACTIV.A.C.™ Therapy Unit

FSCA-ActiVAC-052020

Active wound management

Model: 340001

MHRA reference: 2020/005/021/487/004

June 2020

Implants, active, cardiac programmers and remote monitoring

Model: 24970A, 24967

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

Rocialle: Rocialle

01 June 2020

Surgical devices, non-powered

Model: RML102-909

MHRA reference: 2020/006/001/701/019

Sooil Development: DANA Diabecare RS Update to SOOIL QA-200102-01

20 May 2020

Infusion systems

MHRA reference: 2020/002/014/291/006

Terumo BCT

02 June 2020

Apheresis

Model: ACD-A anticoagulant for apheresis and platelet storage solutions

MHRA reference: 2020/006/001/261/001

Zimmer Biomet: Comprehensive

04 June 2020

Orthopaedic surgical instruments - insertion/extraction tools

Model: Comprehensive® VRS Inserter

MHRA reference: 2020/006/004/487/003

Published 8 June 2020