BEUDAMED
    FDA Enforcement Class II Terminated

    3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod¿, Part Number (Item #) AG8049-NS, Lot # 2528655. K914299. Waste system.

    Recall: Z-0055-2013 · Reported October 17, 2012

    Enforcement

    Recall Number
    Z-0055-2013
    Event ID
    63362
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ICU Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 17, 2012
    Initiation Date
    September 28, 2012
    Classification Date
    October 11, 2012
    Termination Date
    February 19, 2013
    Address
    951 Calle Amanecer, N/A, San Clemente, CA, 92673-6212, United States

    Description

    3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod¿, Part Number (Item #) AG8049-NS, Lot # 2528655. K914299. Waste system.

    Reason

    ICU Medical, Inc. has identified a potential comingling of components where a 60 drop micro drip chamber may have been included on a 20 drop macro drip set.

    Code Info

    Part Number (Item #) AG8049-NS, Lot # 2528655.

    Distribution

    Nationwide distribution: Virginia only.

    Quantity

    60