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Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
FDA product code KPO · Class 2 · Gastroenterology, Urology
678
Registered devices
30,014
Adverse events
113
Recalls
124
510(k) clearances
Devices with this code
RenalPure — ROCKWELL MEDICAL, INC.CitraPure — ROCKWELL MEDICAL, INC.Di-Chem Hemodialysate Additive — Di-Chem, IncorporatedDIASOL — DIASOL, INC.CitriSol — DIASOL, INC.ACCUSOL Dialysis Solution for CRRT — Nikkiso Belgium BVBADi-Chem Hemodialysate Additive — Di-Chem, IncorporatedRenalPure — ROCKWELL MEDICAL, INC.NaturaLyte — Fresenius Medical Care Renal Therapies Group, LLCNxStage PureFlow Solution — NXSTAGE MEDICAL, INC.AcetiCon — Global Scientific TechnologiesNxStage PureFlow-B Solution — NXSTAGE MEDICAL, INC.NxStage PureFlow Solution — NXSTAGE MEDICAL, INC.CitriSol — DIASOL, INC.Citric Complete — NIPRO RENAL SOLUTIONS USA CORPORATIONHemo-Dial — EDLAW PHARMACEUTICALS, INC.Citric Complete — NIPRO RENAL SOLUTIONS USA CORPORATIONNaturaLyte — Fresenius Medical Care Renal Therapies Group, LLCDIASOL — DIASOL, INC.DIASOL — DIASOL, INC.Hemo-Dial — EDLAW PHARMACEUTICALS, INC.Citric Complete — NIPRO RENAL SOLUTIONS USA CORPORATIONCitric Complete — NIPRO RENAL SOLUTIONS USA CORPORATIONCitryte — Di-Chem, Incorporated
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-05 | Nipro Renal Soultions USA, Corporation | Hemodialysis concentrates contain high endotoxin levels |
| 2026-08-05 | Nipro Renal Soultions USA, Corporation | Hemodialysis concentrates contain high endotoxin levels |
| 2026-08-05 | Nipro Renal Soultions USA, Corporation | Hemodialysis concentrates contain high endotoxin levels |
| 2026-08-05 | Nipro Renal Soultions USA, Corporation | Hemodialysis concentrates contain high endotoxin levels |
| 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 occurre |
| 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 correctl |
| 2025-11-05 | Diasol, Inc | Safety and efficacy of dialysis acid concentrate cannot be assured |
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