BEUDAMED
    FDA Recall Terminated

    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 # ZIB6-80-8.0-40.

    Recall: Z-0600-06 · Initiated January 26, 2006

    Recall

    Recall Number
    Z-0600-06
    Event Number
    34657
    Firm
    Cook, Inc.
    FEI Number
    1820334
    Product Code
    FGE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 26, 2006
    Posted
    March 9, 2006
    Terminated
    April 10, 2006
    Address
    750 Daniels Way, Bloomington, IN, 47404-9120

    Description

    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 # ZIB6-80-8.0-40.

    Reason

    The side of the boxes give incorrect sizes for these stents. The label front is correct.

    Action

    Consignees were notified via telephone on 1/26/06 and a follow-up fax was sent.

    Distribution

    California, Pennsylvania, Utah and Canada.

    Quantity

    5