NxStage PureFlow-B Solution (NxStage) – Seal Failure Risk (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
NxStage PureFlow-B Solution. Catalog numbers: RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-406, RFP-453, RFP-454, RFP-456.
Brand
NxStage Medical Inc
Lot Codes / Batch Numbers
a. UDI-DI number: M535RFP4000. Device Catalog Number RFP-400. Lot Numbers: Q2407307, Q2407308, Q2407309. b. UDI-DI number: M535RFP4010. Device Catalog Number RFP-401. Lot Numbers: Q2407061, Q2407147, Q2407148, Q2407149, Q2407313, Q2407386, Q2407387, Q2407388, Q2407389, Q2407390. c. UDI-DI number: M535RFP4020. Device Catalog Number RFP-402. Lot Numbers: Q2407213, 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. f. UDI-DI number: M535RFP4060. Device Catalog Number RFP-406. Lot Numbers: Q2407072, Q2407137, Q2407140, Q2407141, Q2407216, Q2407310, Q2407146, Q2407226. j. UDI-DI number: M535RFP4560. Device Catalog Number RFP-456. Lot Numbers: Q2407138, Q2407139, Q2407142, Q2407143, Q2407144, Q2407227.
Products Sold
a. UDI-DI number: M535RFP4000. Device Catalog Number RFP-400. Lot Numbers: Q2407307, Q2407308, Q2407309. b. UDI-DI number: M535RFP4010. Device Catalog Number RFP-401. Lot Numbers: Q2407061, Q2407147, Q2407148, Q2407149, Q2407313, Q2407386, Q2407387, Q2407388, Q2407389, Q2407390. c. UDI-DI number: M535RFP4020. Device Catalog Number RFP-402. Lot Numbers: Q2407213, Q2407214. d. UDI-DI number: M535RFP4030. Device Catalog Number RFP-403. Lot Number: Q2407311. e. UDI-DI number: M535RFP4040. Device Catalog Number RFP-404. 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. f. UDI-DI number: M535RFP4060. Device Catalog Number RFP-406. Lot Numbers: Q2407072, Q2407137, Q2407140, Q2407141, Q2407216, Q2407310, Q2407312. g. UDI-DI number: M535RFP4530. Device Catalog Number RFP-453. Lot Number: Q2407066. h. UDI-DI number: M535RFP4540. Device Catalog Number RFP-454. Lot Numbers: Q2407145, Q2407146, Q2407226. j. UDI-DI number: M535RFP4560. Device Catalog Number RFP-456. Lot Numbers: Q2407138, Q2407139, Q2407142, Q2407143, Q2407144, Q2407227.
NxStage Medical Inc is recalling NxStage PureFlow-B Solution. Catalog numbers: RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-406, due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
NxStage notified consignees via mail on 04/28/2025. Consignees were instructed to check inventory for affected units and cease use if any are on hand, complete and return the response form, and contact NxStage Customer Service to arrange return of all affected units.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026