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Nipro Renal Soultions USA, Corporation: MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201

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 Liquid Bicarbonate Concentrate REF: BC-100 and BC+201
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
BC-100 - Lot:N4L022 (exp.11/13/2026), N4L037(exp.11/18/2026) BC+201- Lot: N4L010(exp.11/06/2026)
Product quantity
3,286 cases
Voluntary mandated
Voluntary: Firm initiated
City
Lewisberry
State
PA
Country
United States
Event id
99573
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