Recall Z-0879-2015
Ev3, Inc. · initiated December 4, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
ev3, Protg Rx Tapered Carotid Stent System, SEPX-8-6-40-135, 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.
Codes / lots: Lot # 9922795
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.
FDA-determined cause: Packaging process control
Action taken
Consignees were sent on 12/4/2014 a Covidien "Urgent Field Safety Notice" letter dated 4th December 2014. The letter described the problem and the product involved in the recall. Advised consignees to quarantine, discontinue use of the device and return the product to Covidien. They also requested consignees to complete the "Recall Verification Form" and return it to Covidien. For questions, customers can contact their local Covidien Representative.
Details
- Recall number
- Z-0879-2015
- Initiated
- December 4, 2014
- Posted by FDA
- December 29, 2014
- Terminated
- July 17, 2015
- Product code
- NIM – Stent, Carotid
- Quantity
- 24
- Distribution
- International Only Distribution -- RUSSIA, ROMANIA, UNITED KINGDOM, GERMANY, ITALY, SPAIN, FRANCE, TURKEY, POLAND, and JAPAN.
- Recalling firm
- Ev3, Inc., Plymouth, MN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0878-2015 Class II | ev3 Protege Rx Tapered Carotid Stent System, SECX-10-7-40-135, Sterile EO, Rx only.…Two production lots of the Protege Rx Tapered Carotid Stent Systems (SECX-10-7-40-135, Lot # 9922452 &… | 12/04/2014Terminated |