Z-0878-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 7, 2015
- Initiation Date
- December 4, 2014
- Termination Date
- July 17, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14
Product Description
ev3 Protege Rx Tapered Carotid Stent System, SECX-10-7-40-135, Sterile EO, Rx only. Indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require percutaneous carotid revascularization and meet outlined criteria.
Reason for Recall
Two production lots of the Protege Rx Tapered Carotid Stent Systems (SECX-10-7-40-135, Lot # 9922452 & SEPX-8-6-40-135, Lot # 9922795) because of a product labeling error.
Distribution Pattern
International Only Distribution -- RUSSIA, ROMANIA, UNITED KINGDOM, GERMANY, ITALY, SPAIN, FRANCE, TURKEY, POLAND, and JAPAN.
Code Information
Lot # 9922452