Recalls / —
—#31583
Product
Wallstent Rx Biliary Endoprosthesis with Unistep Plus Delivery System 8 Fr, 10mm x 60mm Catalog Number: 6965
- FDA product code
- FGE — Stents, Drains And Dilators For The Biliary Ducts
- Device class
- Class 2
- Medical specialty
- Gastroenterology, Urology
- 510(k) numbers
- K012752, K030107
- Affected lot / code info
- Lot Number: 6023979
Why it was recalled
Incorrect label states stent covered with 'Permalume Covering', product is uncovered
Root cause (FDA determination)
Other
Action the firm took
Boston Scientific notified domestic and international accounts by letter on 1/28/04. Accounts are requested to return product.
Recalling firm
- Firm
- Boston Scientific Corporation
- Address
- 1 Boston Scientific Pl, Natick, Massachusetts 01760-1536
Distribution
- Distribution pattern
- CA, GA, , MD, NY, OR, ND, PA Netherlands
Timeline
- Recall initiated
- 2004-01-28
- Posted by FDA
- 2004-07-20
- Terminated
- 2006-06-28
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #31583. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.