CLASS II ONGOING Device recall · Reported 4 Jun 2025 · FDA Enforcement Report
NxStage PureFlow-B Solution recalled by NxStage Medical
NxStage Medical is recalling NxStage PureFlow-B Solution, distributed nationwide in the US. The recall was initiated on 28 Apr 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1864-2025
- FDA event ID
- 96730
- Recalling firm
- NxStage Medical, Lawrence, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 28 Apr 2025
- FDA classified
- 28 May 2025
- Reported
- 4 Jun 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 28 Apr 2025 | Recall initiated by company | |
| 28 May 2025 | Classified by FDA | +30 days |
| 4 Jun 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
NxStage PureFlow-B Solution. Catalog numbers: RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-406, RFP-453, RFP-454, RFP-456.
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it 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.
Which lots are affected?
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.
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from NxStage Medical
All 31| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | NxStage PureFlow-B Solution, Premixed Dialysate recalled | NxStage Medical | Other | Nationwide |
| Device | CLASS II | Low Volume Cartridge IFU recalled by NxStage Medical | NxStage Medical | Other | 5 states |
| Device | CLASS II | NxStage PureFlow B Solution recalled by NxStage Medical | NxStage Medical | Labeling Errors | Nationwide |
| Device | CLASS II | NxStage PureFlow B Solution recalled by NxStage Medical | NxStage Medical | Labeling Errors | Nationwide |
| Device | CLASS II | NxStage PureFlow B Solution-RFP-403, Premixed Dialysate recalled | NxStage Medical | Other | Nationwide |
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