FDA-Device2025-06-04Class II
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
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.
Sold states
US Nationwide distribution.
Affected count
115,465 cases (230,930 units)
Manufactured in
350 Merrimack St, N/A, Lawrence, MA, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1864-2025Don't want to check this manually?
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