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
Medtronic: CareLink SmartSync Base; CareLink SmartSync Patient Connector
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