Boston Scientific/Microvasive brand Biliary Stent Kit, 7 FR x 10 cm, sterile, single use only; Ref 3102.
FDA device recall Z-1103-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corp
- Reason for recall
- Mislabeled as to length; 5 cm length labeled as 10 cm.
- Action taken
- Consignees were notified via recall letter dated June 18, 2004. Consignees were instructed to call the firm if they had any product in stock.
- Root cause
- Other
- Status
- Terminated
- Product code
- FGE
- Distribution
- California, Hawaii, Kentucky, New Jersey and Oregon.
- Date initiated
- 2004-06-18
- Date posted
- 2004-07-20
- Date terminated
- 2004-12-14
- Location
- Spencer, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DRAINAGE STENT (K834468) | Microvasive | 1984-04-20 |