Class II — Nipro Renal Soultions USA, Corporation
| Recalling firm | Nipro Renal Solutions USA, Corp |
|---|---|
| Registered facility | Nipro Renal Solutions USA, Corporation (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | The outer case is mislabeled as 3.0 K, 2.0 Ca instead of 2.0 K, 3.0 Ca. |
| Product | Citric Complete - Dry Citric Acid Concentrate Model Number: DCA+225-25 |
| Quantity | 2,810 units |
| Distribution | US distribution to states of: AZ, FL, GA, GA, IL, MI, NC, NJ, OH, TN, TX. |
| Initiated | 2024-11-22 |
| Classified | 2025-01-08 |
| Recall number | Z-0820-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Nipro Renal Soultions USA, Corporation (Z-0820-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95878/
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