BEUDAMED
    FDA Recall Terminated

    Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/26 cm, sterile, Cook Urological, Inc., Spencer, IN; Ref EUSCFS-070026-14-13; GPN REF G18127. Ureteral stent.

    Recall: Z-0850-2009 · Initiated July 31, 2008

    Recall

    Recall Number
    Z-0850-2009
    Event Number
    48760
    Firm
    Vance Products Incorporated
    FEI Number
    1825146
    Product Code
    FAD
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    July 31, 2008
    Posted
    January 23, 2009
    Terminated
    November 27, 2009
    Address
    1100 W Morgan St, Spencer, IN, 47460-9426

    Description

    Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/26 cm, sterile, Cook Urological, Inc., Spencer, IN; Ref EUSCFS-070026-14-13; GPN REF G18127. Ureteral stent.

    Reason

    The bond may break where the two materials meet, resulting in separation of the stent.

    Action

    Consignees were notified via "Urgent: Recall Notice" letter dated 7/31/08. The letter described the failure, instructed that the products be isolated and returned to the firm. For additional information, contact Cook Urological at 1-812-339-2235, ext. 7241.

    Distribution

    Nationwide, Australia, Canada, Colombia, Hong Kong, India, Ireland, Israel, Japan, Malaysia, Mexico, South Korea, Taiwan, Venezuela and Viet Nam

    Quantity

    1739 of all products.