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, R…

Recall date

April 28, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1864-2025

FDA classification

Class II

Brand / firm

NxStage Medical Inc

Sold / distributed

US Nationwide distribution.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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