BEUDAMED
    FDA Recall Terminated

    NxStage PureFlow B Solution, REF RFP-400, M535RFP4000 Product NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.

    Recall: Z-1706-2019 · Initiated April 11, 2019

    Recall

    Recall Number
    Z-1706-2019
    Event Number
    82693
    Firm
    NxStage Medical, Inc.
    FEI Number
    3003464075
    Product Code
    KPO
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    April 11, 2019
    Terminated
    June 8, 2020
    Address
    350 Merrimack St, Lawrence, MA, 01843-1748

    Description

    NxStage PureFlow B Solution, REF RFP-400, M535RFP4000 Product 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.

    Action

    On April 11, 2019, NxStage Medical Inc. issued URGENT MEDICAL DEVICE RECALL notices to customers via courier service. Customers were advised to take the following actions: 1. Check all boxes in your Pureflow B solution inventory. If you find any boxes or individual bags of Pureflow B solution from the affected lots listed in the table below, separate them from your other inventory and do not use them. Refer to Appendix A for pictures to assist in locating part or SKU and lot number of your Pureflow B solution inventory. 2. Promptly complete and return the online response form at the link www.novasyte.com/nxstageapr2019 to acknowledge your receipt of this notice, even if you do not have the affected product on hand. 3. Upon completion of the online response form, your facility will be scheduled for a product return pick up date based on the availability you provide. NxStage is partnered with Novasyte to assist in this action. Novasyte specializes in providing outsourced commercial service teams and technologies for the medical device industry. For any assistance regarding this action please contact Novasyte using the information below: Phone: (760) 205-3020 Email: [email protected]

    Distribution

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

    Quantity

    1998 units