BEUDAMED
    FDA Recall Open, Classified

    Naturalyte Liquid Bicarbonate Concentrate, 6.4 Liter Bottle Part Number: 08-4000-LB The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates

    Recall: Z-1639-2014 · Initiated April 10, 2014

    Recall

    Recall Number
    Z-1639-2014
    Event Number
    67922
    Firm
    Fresenius Medical Care Holdings, Inc.
    FEI Number
    3001451489
    Product Code
    KPO
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    April 10, 2014
    Posted
    May 22, 2014
    Address
    920 Winter St, Waltham, MA, 02451-1521

    Description

    Naturalyte Liquid Bicarbonate Concentrate, 6.4 Liter Bottle Part Number: 08-4000-LB The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates

    Reason

    Naturalyte Liquid Bicarbonate maybe contaminated

    Action

    Fresenius Medical Care North America issued an Urgent Medical Device Recall Letter dated April 10, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their stock immediately and determine whether they have any of the affected parts on hand. If customers have the affected product, they were instructed to discontinue use and place all Naturalyte Liquid Bicarbonate Concentrate in a secure area for return to Fresenius Medical Care Renal Therapies Group, LLC (FMC-RTG). Customers will be instructed to contact their Fresenius Medical Care Technical Services Team for instructions on how to return the recalled product. Firm will also conduct 100% telephone calls. If you have any additional questions, please contact your FMCNA Customer Service Team at 1-800-323-5188. Fresenius Medical Care sent an Urgent Expanded Medical Device Recall letter on May 1, 2014 for 9 additional lots. Customers were instructed to complete and return the attached FAX BACK FORM to confirm that they have received the notice and to indicate whether or not they have the affected product in their possession. For questions regarding this recall call 800-662-1237. Firm issued Press on 5/21/14.

    Distribution

    Worldwide Distribution - USA (nationwide) and Canada.

    Quantity

    672,784 units