BEUDAMED
    FDA Recall Open, Classified

    NxStage PureFlow-B Solution. Catalog numbers: RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-406, RFP-453, RFP-454, RFP-456.

    Recall: Z-1864-2025 · Initiated April 28, 2025

    Recall

    Recall Number
    Z-1864-2025
    Event Number
    96730
    Firm
    NxStage Medical Inc
    FEI Number
    3003464075
    Product Code
    KPO
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    April 28, 2025
    Posted
    May 28, 2025
    Address
    350 Merrimack St, Lawrence, MA, 01843-1748

    Description

    NxStage PureFlow-B Solution. Catalog numbers: RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-406, RFP-453, RFP-454, RFP-456.

    Reason

    Potential for the perimeter seal on the small chamber of the two-chamber bag to fail causing the electrolyte fluid to splash into the face of the user when attempting to open the peel seam to mix the two chambers prior to treatment.

    Action

    NxStage notified consignees via mail on 04/28/2025. Consignees were instructed to check inventory for affected units and cease use if any are on hand, complete and return the response form, and contact NxStage Customer Service to arrange return of all affected units.

    Distribution

    US Nationwide distribution.

    Quantity

    115,465 cases (230,930 units)