BEUDAMED
    FDA Recall Terminated

    Cook Urological Black Silicone Filiform Double Pigtail Ureteral Stent Set, 7.0Fr/24cm, sterile, Order Number (REF) 133724.

    Recall: Z-1168-2007 · Initiated June 29, 2007

    Recall

    Recall Number
    Z-1168-2007
    Event Number
    38273
    Firm
    Vance Products Incorporated
    FEI Number
    1825146
    Product Code
    FAD
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 29, 2007
    Terminated
    June 11, 2008
    Address
    1100 W Morgan St, Spencer, IN, 47460-9426

    Description

    Cook Urological Black Silicone Filiform Double Pigtail Ureteral Stent Set, 7.0Fr/24cm, sterile, Order Number (REF) 133724.

    Reason

    The radiographic band may detach from the stent and remain in the patient after removal of the stent.

    Action

    Consignees were notified of the recall via letter dated 6//29/07, which instructed them to quarantine stock on hand and to fax number on hand back to Cook for return authorization.

    Distribution

    Worldwide, including USA, Canada, and Japan.

    Quantity

    75