BEUDAMED
    FDA Enforcement Class II Terminated

    Fresenius Medical Care NaturaLyte Liquid Acid concentrate-Liquid Acid Concentrate for Bicarbonate Hemodialyis Part Number: 08-3251-9

    Recall: Z-0942-2021 · Reported February 10, 2021

    Enforcement

    Recall Number
    Z-0942-2021
    Event ID
    87006
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Fresenius Medical Care Holdings, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 10, 2021
    Initiation Date
    December 17, 2020
    Classification Date
    February 1, 2021
    Termination Date
    January 5, 2023
    Address
    920 Winter St Bld 950, Waltham, MA, 02451-1521, United States

    Description

    Fresenius Medical Care NaturaLyte Liquid Acid concentrate-Liquid Acid Concentrate for Bicarbonate Hemodialyis Part Number: 08-3251-9

    Reason

    Bottles Missing Product Label

    Code Info

    Lot code: 20NTAC040

    Distribution

    Nationwide

    Quantity

    2,280 cases (9,120 bottles)