BEUDAMED
    FDA Enforcement Class II Terminated

    NxStage PureFlow-B Solution, Model/Catalog Number: RFP-401, packaged in a case The NxStage PureFLow-B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.

    Recall: Z-1214-2013 · Reported May 8, 2013

    Enforcement

    Recall Number
    Z-1214-2013
    Event ID
    64820
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    NxStage Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 8, 2013
    Initiation Date
    March 18, 2013
    Classification Date
    May 2, 2013
    Termination Date
    September 17, 2014
    Address
    350 Merrimack Street, Lawrence, MA, 01843-1748, United States

    Description

    NxStage PureFlow-B Solution, Model/Catalog Number: RFP-401, packaged in a case The NxStage PureFLow-B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.

    Reason

    Product may be mislabeled.

    Code Info

    F023444

    Distribution

    Nationwide Distribution including IL, SC, TX, VA, FL, AR, and NY.

    Quantity

    1480 cases (2 bags per case)