Wallstent Enteral Endoprothesis with Unistep Plus Delivery, 20 mm X 90 mm Catalog Number: 6557
FDA device recall Z-1019-03 · posted 2003-07-15 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- Mislabeled: Product is labeled as a 20 mm X 90 mm, but is actually a 22 mm X 60 mm
- Action taken
- Boston Scientific notified domestic and internationnal accounts by letter on 6/26/03. Users are advised to check inventory and return product. A Reply Verification form was required to returned by fax to determine accountability.
- Root cause
- Other
- Status
- Terminated
- Quantity affected
- 23 units
- Distribution
- CO, FL, IA, IL, NY, VT,TX Foreign: Singapore, Korea
- Date initiated
- 2003-06-26
- Date posted
- 2003-07-15
- Date terminated
- 2005-04-21
- Location
- Natick, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| WALLSTENT ENTERAL ENDOPROSTHESIS WITH UNISTEP DELIVERY SYSTEM (K991056) | Boston Scientific Corp | 1999-06-22 |