BEUDAMED
    FDA Recall Terminated

    Cook PTFE Wire Guide with 3 cm flexible tip, to establish a tract for ureteral/renal access, .038", 145 cm; sterile; Order/Ref number 638413.

    Recall: Z-1162-2007 · Initiated June 12, 2007

    Recall

    Recall Number
    Z-1162-2007
    Event Number
    38283
    Firm
    Cook Urological, Inc.
    Product Code
    EZB
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 12, 2007
    Posted
    August 9, 2007
    Terminated
    November 25, 2009
    Address
    1100 W Morgan St, Spencer, IN, 47460-9426

    Description

    Cook PTFE Wire Guide with 3 cm flexible tip, to establish a tract for ureteral/renal access, .038", 145 cm; sterile; Order/Ref number 638413.

    Reason

    Lack of assurance of sterility, in that the product is labeled as sterile but the package may not have been sealed.

    Action

    Consignees were notified via letter dated 6/12/07 and instructed to cease using the product and to inform the firm if they have product to return.

    Distribution

    Nationwide and Canada.

    Quantity

    100