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U.S. Department of Health and Human Services

Enforcement Report - Week of March 20, 2013

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Event Detail

Event ID 64344
Product Type Devices
Status Ongoing
Recalling Firm Sorin C.R.M., srl
City Saluggia, VC
State
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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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 Models: 2CR5, 2CR6 and 2CT6, Distributed From 03/19/08 To 01/21/13 Class II Isoline defibrillation leads distributed may have internal insulation breach. 1376 Isoline leads Z-0928-2013
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