NxStage Medical Inc: Device Recall

Recall #Z-1864-2025 · 04/28/2025

Class II: Risk

Recall Details

Recall Number: Z-1864-2025
Classification: Class II
Product Type: Device
Recalling Firm: NxStage Medical Inc
Status: Ongoing
Date Initiated: 04/28/2025
Location: Lawrence, MA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 115,465 cases (230,930 units)

Reason for Recall

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.

Product 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.

Distribution Pattern

US Nationwide distribution.

Other Recalls by NxStage Medical Inc

Class II: Risk 05/14/2024

The smaller chamber of the two chamber bag is bursting when nurses are attempting to mix the two chambers prior to use. The electrolyte fluid in the small chamber of the NxStage PureFlow B Solution has a pH of less than 2.0. The solution can be harmful if it comes in contact with the eyes or skin, and/or as a result of a slip or fall injury due to spilled fluid.

View all recalls by NxStage Medical Inc →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.