BEUDAMED
    FDA Recall Terminated

    VAMP Direct Draw, Model VMP700 Needleless cannula for sampling blood.

    Recall: Z-0242-04 · Initiated November 20, 2003

    Recall

    Recall Number
    Z-0242-04
    Event Number
    27871
    Firm
    Edwards Lifesciences AG Parque Industrial Itabo Km. 18.5 Carr. Sanchez Haina, San Cristobal Dominican Republic
    FEI Number
    3003081151
    Product Code
    KRA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 20, 2003
    Posted
    December 18, 2003
    Terminated
    November 30, 2004

    Description

    VAMP Direct Draw, Model VMP700 Needleless cannula for sampling blood.

    Reason

    Seal integrity, sterility not assured.

    Action

    Letter was sent to all customers requesting return of the unused lot on 11/20/2003.

    Distribution

    Nationwide.

    Quantity

    21150