Cook Zilver 635 Biliary Stent - Expanding Stent, delivery system length 80 cm, stent diameter 8.0 mm, stent length 40 mm, minimum guiding catheter 8.0 French, minimum sheath 6.0 French, recommended wire guide size .035 inch dia., sterile; Catalog # ZIB6-80-4.0-40.
FDA Recall Z-0080-2007 · Posted 2006-10-28
Recalling FirmCook, Inc.
Recall StatusTerminated
Product CodeFGE
Date Initiated2006-09-21
Date Terminated2007-04-04
Product Quantity5
Reason for Recall
The side of the boxes give incorrect sizes for these stents. The label front is correct. (side label-5x40-front label-8x40)
Firm Action
Consignees were notified via telephone on 9/21/06 and requested to return the recalled product.
Root Cause
Other
Distribution Pattern
Class II Recall - Worldwide distribution ---- USA including the states of Idaho and Indiana, as well as, the country of Canada
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.