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Nipro Renal Soultions USA, Corporation FDA Recalls
6 recalls on file across devices, 1 of them Class I and 6 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201Class IIAug 5, 2026Hemodialysis concentrates contain high endotoxin levels |
| MedicaLyte Bicarbonate Powder REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X, 45X))Class IIAug 5, 2026Hemodialysis concentrates contain high endotoxin levels |
| Citric Complete Liquid Citric Acid Concentrate REF: LC+200-D,LC+201, LC+225(45X)Class IIAug 5, 2026Hemodialysis concentrates contain high endotoxin levels |
| Citric Complete Dry Citric Acid Concentrate REF: DCA+200-25 & DCA+203-25Class IIAug 5, 2026Hemodialysis concentrates contain high endotoxin levels |
| MedicaLyte Liquid Bicarbonate Concentrate. Model Numbers: BC+201 (45X), BC+100 36.83X. Plastic bottle packaged in corClass IApr 11, 2025Potential for the presence of visible foreign matter. |
| Citric Complete - Dry Citric Acid Concentrate Model Number: DCA+225-25Class IINov 22, 2024The outer case is mislabeled as 3.0 K, 2.0 Ca instead of 2.0 |