BEUDAMED
    FDA Recall Terminated

    Naturalyte@ Sodium Bicarbonate Liquid Concentrate, Dialysate Concentrate for Hemodialysis Liquid Part number: 08-4000-LB Formulated to be used with a three stream hemodialysis machine which is calibrated for acid and bicarbonate concentrates

    Recall: Z-2551-2011 · Initiated March 23, 2011

    Recall

    Recall Number
    Z-2551-2011
    Event Number
    58736
    Firm
    Fresenius Medical Care Holdings, Inc.
    FEI Number
    3001451489
    Product Code
    KPO
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    March 23, 2011
    Posted
    June 10, 2011
    Terminated
    September 12, 2012
    Address
    920 Winter St, Waltham, MA, 02451-1521

    Description

    Naturalyte@ Sodium Bicarbonate Liquid Concentrate, Dialysate Concentrate for Hemodialysis Liquid Part number: 08-4000-LB Formulated to be used with a three stream hemodialysis machine which is calibrated for acid and bicarbonate concentrates

    Reason

    Mislabeled: incorrect lot number printed on case labels

    Action

    Fresenius sent an CUSTOMER NOTIFICATION LETTER letter dated April 18, 2011, to all affected customers via Certified Mail, Return Receipt Requested. Fresenius also contacted affected customers by telephone April 18, 2011, The letter identified the product, the problem and the action needed to be taken by customer. Customers were instructed to examine their stock to determine whether they have the incorrect case label and are asked to remove the correctly labeled product from the incorrectly labeled case and discard the case. Acknowledgement forms were Fax-back forms for clinics and mail-back forms (including self-addressed, stamped envelopes), for home patients. Question or concerns should be directed to Fresenius Customer Service Team at 1- 800.323.5188.

    Distribution

    Nationwide Distribution--AL, CA, CT, FL, GA, NJ, NV, NY, OR, PA, and WA

    Quantity

    3,190 cases