FDAApril 28, 2025device
NxStage PureFlow-B Solution. Catalog numbers: RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-406, RFP-453, RFP-454, RFP-456.
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Ongoing
Brands named
nxstage medicalnxstage
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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