NxStage Medical Inc recalls NxStage PureFlow-B Solution. Catalog numbers: RFP-400
Reason for recall
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- NxStage PureFlow-B Solution. Catalog numbers: RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-406, RFP-453, RFP-454RFP-456UDI-DI numberCatalog # Number77 affected lotsQ2407307Q2407308Q2407309M535RFP4010RFP-401Q2407061Q2407147Q2407148
+69 more
Q2407149Q2407313Q2407386Q2407387Q2407388Q2407389Q2407390M535RFP4020RFP-402Q2407213Q2407214M535RFP4030RFP-403Q2407311M535RFP4040RFP-404Q2407062Q2407063Q2407064Q2407065Q2407067Q2407068Q2407069Q2407070Q2407071Q2407217Q2407218Q2407219Q2407220Q2407221Q2407222Q2407223Q2407224Q2407225Q2407301Q2407302Q2407303Q2407304Q2407305Q2407306Q2407391Q2407392Q2407405Q2407406M535RFP4060RFP-406Q2407072Q2407137Q2407140Q2407141Q2407216Q2407310Q2407312M535RFP4530RFP-453Q2407066M535RFP4540RFP-454Q2407145Q2407146Q2407226M535RFP4560RFP-456Q2407138Q2407139Q2407142Q2407143Q2407144Q2407227
What the firm is doing
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.
DistributionShow detailsHide
US Nationwide distribution.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1864-2025
- FDA 510(k) clearance · K053286The device's official FDA premarket clearance record
- FDA device classification · KPOOfficial FDA classification for this device type
- CFR regulation · 21 CFR 876.5820The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find NxStage Medical IncSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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