BEUDAMED
    FDA Enforcement Class III 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 · Reported June 18, 2014

    Enforcement

    Recall Number
    Z-1739-2014
    Event ID
    68135
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Fresenius Medical Care Holdings, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 18, 2014
    Initiation Date
    May 1, 2014
    Classification Date
    June 9, 2014
    Termination Date
    June 15, 2016
    Address
    920 Winter St, N/A, Waltham, MA, 02451-1521, United States

    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

    Code Info

    Lot Number: 14CMLB006

    Distribution

    Distributed in the state of MO.

    Quantity

    12 bottles