BEUDAMED
    FDA Recall Terminated

    Cook brand Embolization Coils, stainless steel, sterile, 20 MM diameter, .038'' (0.97 mm) diameter embolus, 20 MM diameter, 20 MM long For use with .038'' end hole; Reorder # MWCE-38-20-20.

    Recall: Z-0368-06 · Initiated September 26, 2005

    Recall

    Recall Number
    Z-0368-06
    Event Number
    33700
    Firm
    Cook, Inc.
    FEI Number
    1820334
    Product Code
    KRD
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 26, 2005
    Posted
    January 10, 2006
    Terminated
    January 10, 2006
    Address
    750 Daniels Way, Bloomington, IN, 47404-9120

    Description

    Cook brand Embolization Coils, stainless steel, sterile, 20 MM diameter, .038'' (0.97 mm) diameter embolus, 20 MM diameter, 20 MM long For use with .038'' end hole; Reorder # MWCE-38-20-20.

    Reason

    The coil is 20 centimeters in length, but the label states the length is 20 millimeters.

    Action

    Consignees were notified via telephone and recall letter dated September 26, 2005.

    Distribution

    Delaware, New York and Pennsylvania.

    Quantity

    242