Home / Recalls / Medical Devices
NxStage Medical Inc recalls NxStage PureFlow-B Solution. Catalog numbers: RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-406, RFP-453, RFP-454, RF
Recalled June 4, 2025 · FDA recall Z-1864-2025 · NxStage Medical
Hazard
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. · FDA Class II
Units
115,465 cases (230,930 units)
Sold at
US Nationwide distribution.
Description
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
NxStage PureFlow-B Solution. Catalog numbers: RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-406, RFP-453, RFP-454, RFP-456.
Manufacturer(s)
NxStage Medical Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →