BEUDAMED
    FDA Recall Terminated

    NaturaLyte Liquid Bicarbonate Concentrate, 6.4 liter bottle to be used with a hemodialysis unit; 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-1739-2014 · Initiated May 1, 2014

    Recall

    Recall Number
    Z-1739-2014
    Event Number
    68135
    Firm
    Fresenius Medical Care Holdings, Inc.
    FEI Number
    3001451489
    Product Code
    KPO
    Status
    Terminated
    Root Cause
    Equipment maintenance
    Initiated
    May 1, 2014
    Posted
    June 9, 2014
    Terminated
    June 15, 2016
    Address
    920 Winter St, Waltham, MA, 02451-1521

    Description

    NaturaLyte Liquid Bicarbonate Concentrate, 6.4 liter bottle to be used with a hemodialysis unit; 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

    Container cap may contain foreign material- 0.60% - 0.80% Manganese

    Action

    Fresenius Medical notified customer by letter dated 5/1/14 to examine stock immediately and instructed to discontinue use and place all Naturalyte Liquid Bicarbonate Concentrate in a secure area for return to FMC-RTG. The customer instructed to contact the Fresenius Medical Care Customer Service Team for instructions on how to return the recalled product.

    Distribution

    Distributed in the state of MO.

    Quantity

    12 bottles