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Nipro Renal Soultions USA, Corporation: MedicaLyte Bicarbonate Powder REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X, 45X))

Medical DevicesSource: FDA (device) · Date: 2026-09-16

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Nipro Renal Soultions USA, Corporation
Product
MedicaLyte Bicarbonate Powder REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X, 45X))
Reason / hazard
Hemodialysis concentrates contain high endotoxin levels
Classification
Class II
Status
Ongoing
Distribution / sold at
Worldwide - US Nationwide distribution in the states of FL, GA, IL, MD, MI, NC, NJ, NV, OH, PA, and the countries of Guatemala and Panama.
Recall initiated
2026-08-05
Code info
DB+201-2.1: Lot -NDB5E004(exp.4/30/2027) DB+201-25: Lots - NDB5M011(Exp.12/05/2027, NDB4J003(exp.9/25/2026)
Product quantity
2,327 cases
Voluntary mandated
Voluntary: Firm initiated
City
Lewisberry
State
PA
Country
United States
Event id
99573
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