BEUDAMED
    FDA Enforcement Class II Ongoing

    Naturalyte Liquid Acid concentrate bottles, Product Code 08-2251-0 - 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-0833-2021 · Reported January 20, 2021

    Enforcement

    Recall Number
    Z-0833-2021
    Event ID
    86939
    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 23, 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, Product Code 08-2251-0 - 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 deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing specification.

    Code Info

    Lot Numbers: 20LXAC076 20LXAC077 20LXAC091 20LXAC101 20NXAC010 Additional Affected lots as of 3/17/21: 20LXAC053 20LXAC047 20LXAC054 20LXAC049 20NXAC016 20LXAC094 20NXAC024 20NXAC025 20LXAC091 20LXAC101 20LXAC077 20LXAC048 20NXAC010 20LXAC076

    Distribution

    US Nationwide distribution.

    Quantity

    3083 cases