Cook brand Zilver 635 Biliary Stent - Expanding Stent, delivery system length 80 cm, stent diameter 6.0 mm, stent length 60 mm, minimum guiding catheter 8.0 French, minimum sheath 6.0 French, recommended wire guide size .035 inch dia., sterile; Catalog # ZIB6-80-6.0-60.
FDA Recall Z-0391-06 · Posted 2006-01-13
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Recalling FirmCook, Inc.
Recall StatusTerminated
Product CodeFGE
Date Initiated2005-10-24
Date Terminated2006-04-10
Product Quantity9
Reason for Recall
The side of the box gives the size of the stent as 8 x 60 instead of the actual size of 6 x 60. The label front is correct.
Firm Action
Consignees were notified of the initial recall by phone beginning on 10/24/05 and of the extension to the second product on 01/06 /06.
Root Cause
Other
Distribution Pattern
Connecticut, Michigan, Minnesota, Montana, Nevada, Pennsylvania, Utah, Wisconsin and 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.
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