Wallstent Enteral Endoprothesis with Unistep Plus Delivery, 20 mm X 90 mm Catalog Number: 6557
FDA Recall Z-1019-03 · Posted 2003-07-15
Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Date Initiated2003-06-26
Date Terminated2005-04-21
Product Quantity23 units
Reason for Recall
Mislabeled: Product is labeled as a 20 mm X 90 mm, but is actually a 22 mm X 60 mm
Firm Action
Boston Scientific notified domestic and internationnal accounts by letter on 6/26/03. Users are advised to check inventory and return product. A Reply Verification form was required to returned by fax to determine accountability.
Root Cause
Other
Distribution Pattern
CO, FL, IA, IL, NY, VT,TX Foreign: Singapore, Korea
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.