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U.S. Department of Health and Human Services

Enforcement Report - Week of March 20, 2013

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Product Detail

Product Description Isoline Implantable Defibrillation Lead, Model Isoline 2CR5, 2CR6 and 2CT6. These lead models are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening arrhythmias
Recall Number Z-0928-2013
Classification Class II
Code Info Models: 2CR5, 2CR6 and 2CT6, Distributed From 03/19/08 To 01/21/13
Product Distributed Qty 1376 Isoline leads
Reason For Recall Isoline defibrillation leads distributed may have internal insulation breach.

Event Detail

Event Id 64344
Product Type Devices
Status Ongoing
Recalling Firm Sorin C.R.M., srl
City Saluggia, VC
Country IT
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-01-28
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldlwide Distribution - USA (Nationwide) and worldwide to Argentina, Australia, Austria, Belgium, Brazil, Canada, Cuba, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, India, Iran, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Morocco, The Netherlands, Portugal, Russia, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, Tunisia, Ukraine, Uruguay and the United Kingdom.