BEUDAMED
    FDA Enforcement Class II Terminated

    NxStage PureFlow-B Solution; Model/Catalog Number: RFP-401. Product is packaged in a case containing two individual 5L bags. The NxStage PureFlow-B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.

    Recall: Z-1073-2014 · Reported March 5, 2014

    Enforcement

    Recall Number
    Z-1073-2014
    Event ID
    67405
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    NxStage Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 5, 2014
    Initiation Date
    January 24, 2014
    Classification Date
    February 24, 2014
    Termination Date
    August 29, 2014
    Address
    350 Merrimack Street, Lawrence, MA, 01843-1748, United States

    Description

    NxStage PureFlow-B Solution; Model/Catalog Number: RFP-401. Product is packaged in a case containing two individual 5L bags. The NxStage PureFlow-B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.

    Reason

    Mislabeled product.

    Code Info

    Lot Number: F113662

    Distribution

    US Distribution including the states of NY, TX, ID, AR, CA and AL

    Quantity

    969 cases (2 bags per case)