Oasis-One Action Stent Introduction System with ST-2 Soehendra Tannenbaum Biliary Stent, (11.5 French size only), Guidin
FDA device recall Z-0347-04 · posted 2004-01-14 · Terminated
Recall details
- Recalling firm
- Wilson-Cook Medical Inc
- Reason for recall
- Mislabeling; Incorrect statement, Minimum Accessory Channel Size: 3.7mm, should state, Minimum Accessory Channel Size 4.2mm
- Action taken
- Consignee was notified by letter sent via fax on 12/19/2003.
- Root cause
- Other
- Status
- Terminated
- Product code
- FGE
- Quantity affected
- 198 units
- Distribution
- Product was shipped to one distributor in Japan.
- Date initiated
- 2003-12-22
- Date posted
- 2004-01-14
- Date terminated
- 2004-03-23
- Location
- Winston Salem, NC
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ZIMMON BILIARY STENT SET (K851962) | Wilson-Cook Medical, Inc. | 1985-12-17 |