Nipro Renal Soultions USA MedicaLyte Bicarbonate Powder REF: DB+201-2.1(45X) and DB+201-25 recall — FDA Z-3134-2026
Hemodialysis concentrates contain high endotoxin levels
Overview of recall records associated with Nipro Renal Soultions USA, Corporation, including dates, categories and classifications where available.
Classification mix: Class II: 2, Class I: 1.
Hemodialysis concentrates contain high endotoxin levels
Potential for the presence of visible foreign matter.
The outer case is mislabeled as 3.0 K, 2.0 Ca instead of 2.0 K, 3.0 Ca.
This page summarizes recall records in which the official source identifies Nipro Renal Soultions USA, Corporation as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.