BEUDAMED
    FDA Recall Open, Classified

    NaturaLyte Liquid Acid concentrate, Part Number 08-0231-4, four (4) one-gallon bottles per bottle case. For dialysis.

    Recall: Z-0181-2023 · Initiated October 4, 2022

    Recall

    Recall Number
    Z-0181-2023
    Event Number
    90947
    Firm
    Fresenius Medical Care Holdings, Inc.
    FEI Number
    3001451489
    Product Code
    KPO
    Status
    Open, Classified
    Root Cause
    Error in labeling
    Initiated
    October 4, 2022
    Posted
    November 4, 2022
    Address
    920 Winter St, Bld 950, Waltham, MA, 02451-1521

    Description

    NaturaLyte Liquid Acid concentrate, Part Number 08-0231-4, four (4) one-gallon bottles per bottle case. For dialysis.

    Reason

    The "Nominal Chemical Composition" section of the label incorrectly lists 5.62g/L KCL (potassium chloride). 5.62g/L actually corresponds to the CaCl (calcium chloride) content. The product remains potassium free.

    Action

    On October 4, 2022, the firm notified affected customers via Important Medical Device Information letters. Customers were reassured that the product was manufactured according to specification and remains potassium-free. Customers may continue to use the product. Please contact FMCRTG Customer Service at 1-800-323-5188 if you have further questions.

    Distribution

    Domestic distribution to AL AZ CA DC FL GA HI IL IN MD MI MO MS NE NJ NY OH PA SD TX VA No foreign distribution.

    Quantity

    17700