FDAFDA · Food and drugs·Recall number Z-0928-2013
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
Published March 20, 2013 · Recall initiated: January 28, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Isoline defibrillation leads distributed may have internal insulation breach.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Sorin Group USA, Inc.
- Distributor
- 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.
- Lot
- Models: 2CR5, 2CR6 and 2CT6, Distributed From 03/19/08 To 01/21/13
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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