Nipro Renal Soultions USA, Corporation Recalls
6 recalls from federal safety databases (FDA, CPSC). Sourced directly from government enforcement feeds.
Medical Device Recalls (6)
- Class II
August 5, 2026
Citric Complete Liquid Citric Acid Concentrate REF: LC+200-D,LC+201, LC+225(45X)
Hemodialysis concentrates contain high endotoxin levels
- Class II
August 5, 2026
Citric Complete Dry Citric Acid Concentrate REF: DCA+200-25 & DCA+203-25
Hemodialysis concentrates contain high endotoxin levels
- Class II
August 5, 2026
MedicaLyte Bicarbonate Powder REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X, 45X))
Hemodialysis concentrates contain high endotoxin levels
- Class II
August 5, 2026
MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201
Hemodialysis concentrates contain high endotoxin levels
- Class I
April 11, 2025
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).
Potential for the presence of visible foreign matter.
- Class II
November 22, 2024
Citric Complete - Dry Citric Acid Concentrate Model Number: DCA+225-25
The outer case is mislabeled as 3.0 K, 2.0 Ca instead of 2.0 K, 3.0 Ca.
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.