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
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Abbott: TactiCathTM Quartz Contact Force Ablation Catheter
28 May 2020
Therapy tissue ablation
Model: Model PN-004 065 and PN-004 075
MHRA reference:
Boston Scientific: IceFORCE & IcePearl 2.1 CX Cryoablation Needles
92552660-FA
Surgical, cryogenic
MHRA reference:
Cook Medical: Zenith Alpha庐 Abdominal Endovascular Graft
27 May 2020
Implants, non active, endoprostheses for aortic aneurysms
MHRA reference:
KCI Medical: ACTIV.A.C.鈩� Therapy Unit
FSCA-ActiVAC-052020
Active wound management
Model: 340001
MHRA reference:
Medtronic: CareLink SmartSync Base; CareLink SmartSync Patient Connector
June 2020
Implants, active, cardiac programmers and remote monitoring
Model: 24970A, 24967
MHRA reference:
Rocialle: Rocialle
01 June 2020
Surgical devices, non-powered
Model: RML102-909
MHRA reference:
Sooil Development: DANA Diabecare RS Update to
20 May 2020
Infusion systems
MHRA reference:
Terumo BCT
02 June 2020
Apheresis
Model: ACD-A anticoagulant for apheresis and platelet storage solutions
MHRA reference:
Zimmer Biomet: Comprehensive
04 June 2020
Orthopaedic surgical instruments - insertion/extraction tools
Model: Comprehensive庐 VRS Inserter
MHRA reference: