ASAP Channel Cut Biopsy System, 15 gauge Reference Number: 1390
FDA Recall Z-1062-03 · Posted 2003-07-29
Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Date Initiated2003-07-03
Date Terminated2004-06-17
Product Quantity9455 units
Reason for Recall
Sterility of the device may b e compromised due to a lack of package integrity
Firm Action
Boston Scientific notified accounts by letter on 7/3/03. Accounts are requested to check inventory and return product. A Veification Form was requested to be completed.
Root Cause
Other
Distribution Pattern
Nationwide
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.