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NxStage PureFlow-B Solution
NXSTAGE MEDICAL, INC. · Model RFP-400-BB · UDI-DI 00842289101258
KPO
Prescription
10
510(k) clearances
30,008
Adverse events (23,081 deaths)
109
Recalls
34
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-14 | Fresenius Medical Care Renal Therapies Group, LLC | Complaints of blue-green discoloration in product |
| 2026-07-14 | Fresenius Medical Care Renal Therapies Group, LLC | Complaints of blue-green discoloration in product |
| 2026-07-14 | Fresenius Medical Care Renal Therapies Group, LLC | Complaints of blue-green discoloration in product |
| 2026-05-12 | Fresenius Medical Care Holdings, Inc. | Given the increased number of leaks reported by users, it was determined to be the appropriate course of action to notify users of the potential for the occurrence of Bicarby luer- |
| 2026-05-07 | Fresenius Medical Care Holdings, Inc. | There is an error in the labeling of the GTIN on the product. When scanned; however, the case labeling, lot number, and printed labeling on the product correctly identifies the pro |
| 2025-11-05 | Diasol, Inc | Safety and efficacy of dialysis acid concentrate cannot be assured |
| 2025-11-05 | Diasol, Inc | Safety and efficacy of dialysis acid concentrate cannot be assured |
| 2025-11-05 | Diasol, Inc | Safety and efficacy of dialysis acid concentrate cannot be assured |
| 2025-11-05 | Diasol, Inc | Safety and efficacy of dialysis acid concentrate cannot be assured |
| 2025-11-05 | Diasol, Inc | Safety and efficacy of dialysis acid concentrate cannot be assured |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.