Class I — 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 I |
| Status | Ongoing |
| Reason | Potential for the presence of visible foreign matter. |
| Product | MedicaLyte Liquid Bicarbonate Concentrate. Model Numbers: BC+201 (45X), BC+100 36.83X. Plastic bottle packaged in corrugated shipper cases (4 bottles per shipper case). |
| Quantity | 816,840 units (BC+201), 39,228 units (BC+100) |
| Distribution | US Nationwide distribution in the states of AZ, CA, CO, DE, FL, GA, IL, KS, LA, MA, MI, MN, MO, NC, NJ, NV, NY, OH, OK, OR, PA, SC, TX, UT, VA, WA, PR. International distribution to Guatemala and Panama. |
| Initiated | 2025-04-11 |
| Classified | 2025-05-14 |
| Recall number | Z-1730-2025 |
| 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 I recall — Nipro Renal Soultions USA, Corporation (Z-1730-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96646/
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