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 |
| 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. |
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