Recall Z-0563-04 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Boston Scientific Corporation
Wallstent Rx Biliary Endoprosthesis with Unistep Plus Delivery System 8 Fr, 10mm x 60mm Catalog Number: 6965
| Date | Jul 20, 2004 (initiated Jan 28, 2004) |
| Status | Terminated |
| Reason | Incorrect label states stent covered with 'Permalume Covering', product is uncovered |
| Root cause | Other |
| Action | Boston Scientific notified domestic and international accounts by letter on 1/28/04. Accounts are requested to return product. |
| Quantity | 12 units |
| Distribution | CA, GA, , MD, NY, OR, ND, PA Netherlands |
| FDA record | Open on fda.gov |