Protg Self-Expanding Nitinol Stent 6 mm x 40 mm, Model Number SER6-6-40-135
FDA device recall Z-0863-03 · posted 2003-05-22 · Terminated
Recall details
- Recalling firm
- ev3, Inc.
- Reason for recall
- The label had an expiration date of August 2005, but the correct expiration date was February 2005.
- Action taken
- A Device Recall letter dated April 15, 2003 requested that the consignees hold the product for retrieval by the firm's representatives.
- Root cause
- Other
- Status
- Terminated
- Product code
- FGE
- Quantity affected
- 15 units
- Distribution
- Nationwide in United States.
- Date initiated
- 2003-04-15
- Date posted
- 2003-05-22
- Date terminated
- 2004-07-02
- Location
- St. Paul, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY (K023243) | Sulzer Intratherapeutics, Inc. | 2002-12-13 |