Reported Jun 4, 2025 · Ongoing
NxStage PureFlow-B Solution. Catalog numbers: RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-406, RFP-453, RFP-454,…
NxStage Medical Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: NxStage Medical Inc · 350 Merrimack St · Lawrence, MA · 01843-1748
Is this the product you have?
- NxStage PureFlow-B Solution
- Catalog numbers
RFP-400RFP-401RFP-402RFP-403RFP-404RFP-406RFP-453RFP-454RFP-456
- Lot codes and dates
9 of 9 products
Products covered by this recall Model / number Product as published RFP-400.UDI-DI number: M535RFP4000. Device Lot Numbers: Q2407307, Q2407308, Q2407309. RFP-401.UDI-DI number: M535RFP4010. Device Lot Numbers: Q2407061, Q2407147, Q2407148, Q2407149, Q2407313, Q2407386, Q2407387, Q2407388, Q2407389, Q2407390. RFP-402.UDI-DI number: M535RFP4020. Device Lot Numbers: Q2407213, Q2407214. RFP-403.UDI-DI number: M535RFP4030. Device Lot Number: Q2407311. RFP-404.UDI-DI number: M535RFP4040. Device Lot Numbers: Q2407062, Q2407063, Q2407064, Q2407065, Q2407067, Q2407068, Q2407069, Q2407070, Q2407071, Q2407217, Q2407218, Q2407219, Q2407220, Q2407221, Q2407222, Q2407223, Q2407224, Q2407225, Q2407301, Q2407302, Q2407303, Q2407304, Q2407305, Q2407306, Q2407391, Q2407392, Q2407405, Q2407406. RFP-406.UDI-DI number: M535RFP4060. Device Lot Numbers: Q2407072, Q2407137, Q2407140, Q2407141, Q2407216, Q2407310, Q2407312. RFP-453.UDI-DI number: M535RFP4530. Device Lot Number: Q2407066. RFP-454.UDI-DI number: M535RFP4540. Device Lot Numbers: Q2407145, Q2407146, Q2407226. RFP-456.UDI-DI number: M535RFP4560. Device Lot Numbers: Q2407138, Q2407139, Q2407142, Q2407143, Q2407144, Q2407227. - Amount recalled
- 115,465 cases (230,930 units)
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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