BEUDAMED
    FDA Recall Terminated

    Fresenius Medical Care NaturaLyte Liquid Acid concentrate-Liquid Acid Concentrate for Bicarbonate Hemodialyis Part Number: 08-3251-9

    Recall: Z-0942-2021 · Initiated December 17, 2020

    Recall

    Recall Number
    Z-0942-2021
    Event Number
    87006
    Firm
    Fresenius Medical Care Holdings, Inc.
    FEI Number
    3001451489
    Product Code
    KPO
    Status
    Terminated
    Root Cause
    Packaging change control
    Initiated
    December 17, 2020
    Terminated
    January 5, 2023
    Address
    920 Winter St, Bld 950, Waltham, MA, 02451-1521

    Description

    Fresenius Medical Care NaturaLyte Liquid Acid concentrate-Liquid Acid Concentrate for Bicarbonate Hemodialyis Part Number: 08-3251-9

    Reason

    Bottles Missing Product Label

    Action

    Fresenius Medical Care (FMCRTG isssued URGENT MEDICAL DEVICE RECALL on 12/17/20 ia First Class Mail, letter states reason for recall, health risk and action to take: RETURN ONLY BOTTLES WITH NO LABEL OPEN AND CHECK ALL BOTTLES IN CASES of Lot Number 20NTAC040. " If you find any bottles from this lot with no labels, place the product in a secure, segregated area. Please contact FMCRTG Customer Service at 1-800-323-5188 for instructions on how to return the product and receive credit. o If returning single bottles, please place affected product in a box for pick up. Please contact FMCRTG Customer Service at 1-800-323-5188 if you have unique circumstances or an urgent need concerning product delivery.

    Distribution

    Nationwide

    Quantity

    2,280 cases (9,120 bottles)