BEUDAMED
    FDA Enforcement Class II Ongoing

    NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2351-8 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

    Recall: Z-0817-2021 · Reported January 20, 2021

    Enforcement

    Recall Number
    Z-0817-2021
    Event ID
    86855
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Fresenius Medical Care Holdings, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 20, 2021
    Initiation Date
    November 7, 2020
    Classification Date
    January 11, 2021
    Address
    920 Winter St Bld 950, N/A, Waltham, MA, 02451-1521, United States

    Description

    NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2351-8 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

    Reason

    The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.

    Code Info

    Lot Numbers: 20LXAC097 Additional affected lot as of 3/17/21: 20NXAC033

    Distribution

    US Nationwide distribution.

    Quantity

    577 cases