BEUDAMED
    FDA Enforcement Class I Terminated

    Alaris Medley LVP Frame Membrane. Intended use to hold platen assembly and help protect the bezel assembly's internal components from fluid intrusion. This part is used in the Alaris Medley LVP 8100 infusion pump.

    Recall: Z-2371-2015 · Reported August 26, 2015

    Enforcement

    Recall Number
    Z-2371-2015
    Event ID
    71543
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Elite Biomedical Solutions LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 26, 2015
    Initiation Date
    June 3, 2015
    Classification Date
    August 19, 2015
    Termination Date
    March 7, 2017
    Address
    5150 Fordon Ct, Cincinnati, OH, 45244-5021, United States

    Description

    Alaris Medley LVP Frame Membrane. Intended use to hold platen assembly and help protect the bezel assembly's internal components from fluid intrusion. This part is used in the Alaris Medley LVP 8100 infusion pump.

    Reason

    Administration of inappropriate quantities of fluid can result, with the potential to cause injury or death.

    Code Info

    P/N TC10006587 and 10013801 Lot Numbers 022015502 and 0421151000.

    Distribution

    Nationwide Distribution in the states of AZ, CA, GA, IL, IN, KS, KY, MA, MD, MN, MO, MS, NC, NY, OH, PA, SC, TN, TX, VA & WI.

    Quantity

    609 pieces