BEUDAMED
    FDA Recall Terminated

    Edwards Protection Cannulae - Monitoring and Infusion Set, Model MIS004, Sterile EO, Edwards Lifesciences LLC, One Edwards Way, Irvine, CA 92614.

    Recall: Z-0543-2011 · Initiated October 19, 2010

    Recall

    Recall Number
    Z-0543-2011
    Event Number
    57143
    Firm
    Edwards Lifesciences Llc
    FEI Number
    1713910
    Product Code
    DTL
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    October 19, 2010
    Posted
    December 7, 2010
    Terminated
    May 18, 2011
    Address
    12050 Lone Peak Parkway, Draper, UT, 84020-9414

    Description

    Edwards Protection Cannulae - Monitoring and Infusion Set, Model MIS004, Sterile EO, Edwards Lifesciences LLC, One Edwards Way, Irvine, CA 92614.

    Reason

    Monitoring and Infusion Set connectors may break during manipulation.

    Action

    Edwards Lifesciences issued a Urgent Product Recall letter dated October 13, 2010 to customers identifying the affected devices, requesting the return of unused devices and completion and return of a response form. Further information is available at 800-424-3278.

    Distribution

    Nationwide Distribution: in the states of FL, KS, MO, TX, VA, and PR.

    Quantity

    570 sets