BEUDAMED
    FDA Recall Terminated

    NaturaLyte Liquid Acid Concentrate 2.0 mEq/L, Model # 08-2251-0 3.43 liter bottle This concentrate is formulated to be used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

    Recall: Z-1010-2018 · Initiated September 29, 2017

    Recall

    Recall Number
    Z-1010-2018
    Event Number
    79236
    Firm
    Fresenius Medical Care Renal Therapies Group, LLC
    FEI Number
    3001451489
    Product Code
    KPO
    Status
    Terminated
    Root Cause
    Release of Material/Component prior to receiving test results
    Initiated
    September 29, 2017
    Terminated
    August 9, 2018
    Address
    920 Winter St, Waltham, MA, 02451-1521

    Description

    NaturaLyte Liquid Acid Concentrate 2.0 mEq/L, Model # 08-2251-0 3.43 liter bottle This concentrate is formulated to be used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

    Reason

    The label specifies the potassium concentration is 2.0 mEq/L. Some of the product in the affected lot was found to have a potassium concentration of 2.25 mEq/L.

    Action

    The firm, Fresenius Medical Care, sent an "URGENT - MEDICAL DEVICE RECALL" letter dated 10/4/2017 to its Consignees. The letter described the product, problem and actions to be taken. The Consignees are instructed to: " Immediately examine your stock to determine whether you have any Naturalyte Liquid Acid Concentrate from the lot listed. " If any product of this lot is found, discontinue use immediately. " Place all units in a secure, segregated area. " Contact your FMCRTG, LLC Customer Service Team at 1-800-323-5188 for instructions on how to return the recalled product. " Promptly fill out and return the attached Reply Form via fax to: 781-699-9796 ATTN: Quality Department or SCAN and email to: [email protected].' and "Route the letter to others in your organization that may have any of the affected product that is subject to this recall. Please note that the Naturalyte Liquid Acid Concentrate matching the Lot Number listed in the notification is the only lot subject to this recall. If you have any additional medical concerns or questions, please contact Medical Information and Communication: 855-616-2309 or Website: www.fresenius-medinfo.com.

    Distribution

    US Distribution to states of: CA, FL, KS, LA, and TX.

    Quantity

    598 cases