BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1311-2022 · Initiated June 1, 2022

    Recall

    Recall Number
    Z-1311-2022
    Event Number
    90419
    Firm
    Fresenius Medical Care Holdings, Inc.
    FEI Number
    3001451489
    Product Code
    KPO
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    June 1, 2022
    Terminated
    October 7, 2024
    Address
    920 Winter St, Bld 950, Waltham, MA, 02451-1521

    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.

    Action

    On June 1, 2022, the firm reached out to its affected customers via telephone to explain the product issue. Customers were instructed to identify and segregate the affected product immediately and remove the product from inventory. If customers had any product to return, the recalling firm would have a customer service representative follow up with the customer. Customers were reminded to always inspect packaging for leaks.

    Distribution

    US Nationwide distribution in the states of Texas and Louisiana.

    Quantity

    3 cases