BEUDAMED
    FDA Enforcement Class II Terminated

    NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3

    Recall: Z-1311-2022 · Reported July 13, 2022

    Enforcement

    Recall Number
    Z-1311-2022
    Event ID
    90419
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Fresenius Medical Care Holdings, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    July 13, 2022
    Initiation Date
    June 1, 2022
    Classification Date
    July 1, 2022
    Termination Date
    October 7, 2024
    Address
    920 Winter St Bld 950, N/A, Waltham, MA, 02451-1521, United States

    Description

    NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3

    Reason

    The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging. Leaks can lead to biological contamination and therefore an increased risk of potential bloodstream infection.

    Code Info

    UDI: (01)00840861101702 (17) 230131 (10) 21AGAC009 Lot 21AGAC009

    Distribution

    US Nationwide distribution in the states of Texas and Louisiana.

    Quantity

    3 cases