BEUDAMED
    FDA Enforcement Class I Terminated

    Alaris Infusion Pump 8100 Bezel (plastic piece only), Part: TIPA-8100-4410

    Recall: Z-1332-2021 · Reported April 14, 2021

    Enforcement

    Recall Number
    Z-1332-2021
    Event ID
    87470
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Tenacore LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 14, 2021
    Initiation Date
    February 25, 2021
    Classification Date
    April 2, 2021
    Termination Date
    August 5, 2024
    Address
    1525 E Edinger Ave, N/A, Santa Ana, CA, 92705-4907, United States

    Description

    Alaris Infusion Pump 8100 Bezel (plastic piece only), Part: TIPA-8100-4410

    Reason

    Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may over time experience cracking or separation of the posts from the bezel. The separation of one or more bezel repair part posts may result in free flow, over infusion, under infusion or interruption of infusion.

    Code Info

    Parts distributed between July 10, 2020 and January 22, 2021. Time stamp at bezel rear side shows 5 or 6 SO Numbers: 271111, 263873, 264442, 264890, 268606, 269930, 270760, 270936, 271211, 272860, 267603, 268936, 269258, 269291, 272496, 272225, 271408, 267392

    Distribution

    US distribution to states of: WA, AZ, NY, TX, LA, CA, NV, ME, MN, DE, NC, FL, MO, KY, TN, and PA

    Quantity

    1494