Recall Z-0863-03 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
ev3, Inc.
Protg Self-Expanding Nitinol Stent 6 mm x 40 mm, Model Number SER6-6-40-135
| Date | May 22, 2003 (initiated Apr 15, 2003) |
| Status | Terminated |
| Reason | The label had an expiration date of August 2005, but the correct expiration date was February 2005. |
| Root cause | Other |
| Action | A Device Recall letter dated April 15, 2003 requested that the consignees hold the product for retrieval by the firm's representatives. |
| Quantity | 15 units |
| Distribution | Nationwide in United States. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023243 | MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY Sulzer Intratherapeutics, Inc., Dec 13, 2002 |