BEUDAMED
    FDA Recall Open, Classified

    NATURALYTE Liquid Acid 3.0K 3.0Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure Part Number: 08-3301-2

    Recall: Z-1371-2022 · Initiated May 31, 2022

    Recall

    Recall Number
    Z-1371-2022
    Event Number
    90438
    Firm
    Fresenius Medical Care Holdings, Inc.
    FEI Number
    3001451489
    Product Code
    KPO
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    May 31, 2022
    Address
    920 Winter St, Bld 950, Waltham, MA, 02451-1521

    Description

    NATURALYTE Liquid Acid 3.0K 3.0Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure Part Number: 08-3301-2

    Reason

    Alternate Bottle Caps labeled with "Sealed for your Protection" on the foil not qualified for use

    Action

    Fresenius Medical Care issued Urgent Medical Device Recall letter (FA-2022-11-T) dated 6/2/22. Letter states reason for recall, health risk and action to take: These instructions apply only to clinics directly contacted by the Fresenius Medical Care Corrections and Removals Department. " Immediately examine your stock to determine whether you have NaturaLyte Liquid Acid concentrate with the part and lot numbers listed below. " Only bottles with sealed for your protection on the bottle cap foil are affected (see picture below). " Remove the affected product from your inventory. " FMCRTG, LLC will contact you regarding product return. Please contact FMCRTG Customer Service at 1-800-323-5188 if you have any further questions.

    Distribution

    Natiowide

    Quantity

    163 cases