Wallstent Rx Biliary Endoprosthesis with Unistep Plus Delivery System 8 Fr, 10mm x 60mm Catalog Number: 6965
FDA Recall Z-0563-04 · Posted 2004-07-20
Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeFGE
Date Initiated2004-01-28
Date Terminated2006-06-28
Product Quantity12 units
Reason for Recall
Incorrect label states stent covered with 'Permalume Covering', product is uncovered
Firm Action
Boston Scientific notified domestic and international accounts by letter on 1/28/04. Accounts are requested to return product.
Root Cause
Other
Distribution Pattern
CA, GA, , MD, NY, OR, ND, PA Netherlands
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.