BEUDAMED
    FDA Enforcement Class II Terminated

    NxStage PureFlow B Solution, REF RFP-401, M535RPF4010 NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.

    Recall: Z-1707-2019 · Reported June 12, 2019

    Enforcement

    Recall Number
    Z-1707-2019
    Event ID
    82693
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    NxStage Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 12, 2019
    Initiation Date
    April 11, 2019
    Classification Date
    June 2, 2019
    Termination Date
    June 8, 2020
    Address
    350 Merrimack St, Lawrence, MA, 01843-1748, United States

    Description

    NxStage PureFlow B Solution, REF RFP-401, M535RPF4010 NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.

    Reason

    Certain lots were mislabeled with incorrect product number.

    Code Info

    Lot Number: Q1811789 & Q1811790 Exp Date: 11/1/2020

    Distribution

    US Nationwide Distribution - AZ, CA, DC, FL, GA, IL, IN, MI, NC, NH, NV, PA, TX & VA

    Quantity

    3,940 units