BEUDAMED
    FDA Enforcement Class II Ongoing

    NaturaLyte Liquid Bicarbonate Concentrate (Dialysate Concentrate for Hemodialysis (liquid), 6.4 Liter Bottle Catalog Number: 08-4000-LB This concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates.

    Recall: Z-1827-2015 · Reported July 1, 2015

    Enforcement

    Recall Number
    Z-1827-2015
    Event ID
    71160
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Fresenius Medical Care Holdings, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 1, 2015
    Initiation Date
    May 20, 2015
    Classification Date
    June 22, 2015
    Address
    920 Winter St, Waltham, MA, 02451-1521, United States

    Description

    NaturaLyte Liquid Bicarbonate Concentrate (Dialysate Concentrate for Hemodialysis (liquid), 6.4 Liter Bottle Catalog Number: 08-4000-LB This concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates.

    Reason

    Bacterial contamination.

    Code Info

    Affected lots begin with: 14DMLB, 14EMLB, 14HMLB, 14JMLB, 14KMLB, 14LMBL, 14NMLB, 14PMLB, and 14SMLB.

    Distribution

    Nationwide Distribution

    Quantity

    1,856,619 Bottles