Boston Scientific Sentinol Self-Expanding Nitinol Biliary Stent System with Over-the-Wire Delivery System. Catalog No. 3
FDA device recall Z-0440-06 · posted 2006-01-25 · Terminated
Recall details
- Recalling firm
- Boston Scientific Scimed
- Reason for recall
- One lot of one catalog number of the Sentinol Nitinol Biliary Stent System may have been packaged in a Sentinol nitinol Vascular outer carton. The product, pouch label and carton label are all correct and the correct DFU is in the package.
- Action taken
- A Recall Notice, dated 05/14/04, was sent to appropriate hospital personnel. The Notice described the issue, identified affected product and asked that the use of affected product be discontinued and affected units be segregated. A tracking/verification form is asked to be returned to Boston Scientific and arrangements will be made for retuning the affected product.
- Root cause
- Other
- Status
- Terminated
- Product code
- FGE
- Quantity affected
- 20
- Distribution
- Within US to KY, MA, NC, NH, NJ, PA, TX, VA, WA. The following countries were contacted regarding the recall and all reported that no accounts had affected product in their possession: Argentina, Aust
- Date initiated
- 2004-05-14
- Date posted
- 2006-01-25
- Date terminated
- 2007-01-23
- Location
- Maple Grove, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SENTINOL NITINOL BILLARY STENT SYSTEM (K032025) | Boston Scientific Corp | 2003-09-25 |