BEUDAMED
    FDA Enforcement Class II Terminated

    Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction with bicarbonate in a compatible artificial kidney (hemodialysis) machine.

    Recall: Z-1859-2021 · Reported June 23, 2021

    Enforcement

    Recall Number
    Z-1859-2021
    Event ID
    87894
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medivators, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    June 23, 2021
    Initiation Date
    April 20, 2021
    Classification Date
    June 15, 2021
    Termination Date
    July 11, 2024
    Address
    14605 28th Ave N, Plymouth, MN, 55447-4822, United States

    Description

    Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction with bicarbonate in a compatible artificial kidney (hemodialysis) machine.

    Reason

    The lot may have experienced an anomaly during the manufacturing process, that could lead to an out of specification concentrate formulation.

    Code Info

    Lot 489224

    Distribution

    US Nationwide distribution in the states of IA, IL, MN, ND, NY, OH, SD,WI.

    Quantity

    1,381 CASES