BEUDAMED
    FDA Enforcement Class I Ongoing

    Alaris Infusion Pump Module, Model 8100, serviced/repaired by The Biomed Guys, with the impacted bezel repair part, TIPA-8100-4410 / Alaris 8100 Bezel.

    Recall: Z-1651-2021 · Reported June 9, 2021

    Enforcement

    Recall Number
    Z-1651-2021
    Event ID
    87768
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    The Biomed Guys
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 9, 2021
    Initiation Date
    March 25, 2021
    Classification Date
    June 1, 2021
    Address
    1865 Ashland City Rd Ste H, Clarksville, TN, 37043-6455, United States

    Description

    Alaris Infusion Pump Module, Model 8100, serviced/repaired by The Biomed Guys, with the impacted bezel repair part, TIPA-8100-4410 / Alaris 8100 Bezel.

    Reason

    Bezel repair part, not by the original manufacturer, used in the service and repair of Alaris Pump Module Model 8100, may experience cracking and/or separation of the bezel posts. Separation of one or more bezel posts could lead to free flow, over infusion, under infusion, or interruption of infusion.

    Code Info

    Serial numbers of serviced devices, serviced 09/2020-02-2021: 12833065, 13187021, 13187811, 12838069, 12982509, 12837231, 12835186, 12837972, 12710593, 12776790, 13753893, 13605919, 12832544, 15763526, 14806203, 14806612, 14807070, 13738432, 15763547, 15865626, 14806472, 12796415,

    Distribution

    Us distribution to the states of IN and TX.

    Quantity

    22 units