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ACCUSOL Dialysis Solution for CRRT
Nikkiso Belgium BVBA · Model 30 2K+ · UDI-DI 09349285000185
KPO
Prescription
1
510(k) clearances
30,009
Adverse events (23,081 deaths)
113
Recalls
34
Facilities
Description
Accusol 30 2K+ Solution is indicated for use as dialysis solutions in Continuous Renal Replacement Therapy.
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 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 |
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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.