BEUDAMED
    FDA Recall Terminated

    Cook Flexor DL Dual Lumen Ureteral Access Sheath with AQ Coating, sterile, REF FUS-095013-DL.

    Recall: Z-0377-2007 · Initiated January 5, 2007

    Recall

    Recall Number
    Z-0377-2007
    Event Number
    37115
    Firm
    Cook Urological, Inc.
    FEI Number
    1825146
    Product Code
    FED
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 5, 2007
    Posted
    January 25, 2007
    Terminated
    May 1, 2008
    Address
    1100 W Morgan St, Spencer, IN, 47460-9426

    Description

    Cook Flexor DL Dual Lumen Ureteral Access Sheath with AQ Coating, sterile, REF FUS-095013-DL.

    Reason

    Lack of assurance of sterility, as the packages may not have been sealed.

    Action

    Consignees were notified via recall letter dated 1/5/07 and requested to return the product.

    Distribution

    Massachusetts, Maine, New Hampshire and Puerto Rico.

    Quantity

    4