Home › Device types › KPO
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
FDA product code KPO · Class 2 · Gastroenterology, Urology
663
Registered devices
30,008
Adverse events
106
Recalls
123
510(k) clearances
Devices with this code
Sol-Cart B® — B.Braun Avitum AGDi-Chem Hemodialysate Additive — Di-Chem, IncorporatedDIASOL — DIASOL, INC.Hemo-Dial — EDLAW PHARMACEUTICALS, INC.Citric Complete — NIPRO RENAL SOLUTIONS USA CORPORATIONDIASOL — DIASOL, INC.Citrasate Dry — Fresenius Medical Care Renal Therapies Group, LLCPrismaSATE — BAXTER INTERNATIONAL INC.MedicaPure — NIPRO RENAL SOLUTIONS USA CORPORATIONBicarby — Fresenius Medical Care Renal Therapies Group, LLCDIASOL — DIASOL, INC.Citrasate — Fresenius Medical Care Renal Therapies Group, LLCDIASOL — DIASOL, INC.DIASOL — DIASOL, INC.Hemo-Dial — EDLAW PHARMACEUTICALS, INC.Hemo-Dial — EDLAW PHARMACEUTICALS, INC.DIASOL — DIASOL, INC.Citrasate Dry — Fresenius Medical Care Renal Therapies Group, LLCDIASOL — DIASOL, INC.MedicaPure — DIMESOL USA, LLCDriSate — ROCKWELL MEDICAL, INC.DIASOL — DIASOL, INC.DIASOL — DIASOL, INC.DIASOL — DIASOL, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 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 |
| 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 |
| 2025-04-28 | NxStage Medical Inc | 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 atte |
| 2025-04-11 | Nipro Renal Soultions USA, Corporation | Potential for the presence of visible foreign matter. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.