Class II

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

NxStage Medical Inc · April 28, 2025

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.

Distribution

US Nationwide distribution.

States Affected

NATIONWIDE

Quantity Affected

115,465 cases (230,930 units)

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1864-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.