Boston Scientific Flexima Biliary Stent System, 200 cm long, .035" (0.89 mm), sterile, Boston Scientific, Spencer, IN; R
FDA device recall Z-2105-2008 · posted 2008-09-11 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corp
- Reason for recall
- Rapid Exchange Biliary Stent may be mislabeled as Flexima biliary Stent, which has a different delivery system included in the package.
- Action taken
- An Urgent Medical Device Recall-Immediate Action Required letter was sent to consignees on 4/2/08 directing them to immediately discontinue use of and segregate the identified products for return to the firm and complete the verification tracking form.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- FGE
- Quantity affected
- 80
- Distribution
- Class III Recall - Worldwide Distribution --- including USA and countries of Finland, France, Germany and Great Britain.
- Date initiated
- 2008-04-02
- Date posted
- 2008-09-11
- Date terminated
- 2008-09-11
- 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 |
|---|---|---|
| BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS (K965147) | Boston Scientific Corp | 1997-06-30 |