Boston Scientific/Microvasive brand Biliary Stent Kit, 7 FR x 5 cm, sterile, single use only; Ref 3101.
FDA Recall Z-1102-04 · Posted 2004-07-20
Recalling FirmBoston Scientific Corp
Recall StatusTerminated
Product CodeFGE
Date Initiated2004-06-18
Date Terminated2004-12-14
Reason for Recall
Mislabeled as to length; 10 cm length labeled as 5 cm.
Firm Action
Consignees were notified via recall letter dated June 18, 2004. Consignees were instructed to call the firm if they had any product in stock.
Root Cause
Other
Distribution Pattern
California, Hawaii, Kentucky, New Jersey and Oregon.
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.