Wallstent Endoscopic Biliary Endoprosthesis 10mm x 80mm, UPN H965430600
FDA device recall Z-0609-2007 · posted 2007-03-13 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- Guidewire restriction during use (excessive adhesive in the guidewire lumen)
- Action taken
- On December 20, 2006, Boston Scientific notified all US consignees by letter sent via Fed Ex Priority mail. Customers are instructed to remove affected product from inventory and return it to Boston Scientific. The notification also requested the completion of a Reply Verification Tracking Form as a method of documenting the presence or absence of affected product in inventory. Boston Scientific International Regulatory Affairs was notified and is responsible the monitoring foreign recall.
- Root cause
- Other
- Status
- Terminated
- Product code
- FGE
- Quantity affected
- 8,511 for Recalls Z-0604-0609-2007
- Distribution
- Worldwide distribution --- USA and countries of Austria, Belgium, France, Czech Republic, Germany, great Britain, Greece,Ireland, Italy, Luxemburg, Netherlands, Norway, Poland, Portugal, Spain, Switze
- Date initiated
- 2006-12-20
- Date posted
- 2007-03-13
- Date terminated
- 2007-12-12
- 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 TRANSHEPATIC BILIARY ENDOPROSTHESIS (K964119) | Boston Scientific Scimed, Inc. | 1997-04-28 |