Class IIDeviceOngoing

Nipro Renal Soultions USA, Corporation

MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201

Reason for recall

Hemodialysis concentrates contain high endotoxin levels

Details

Recall number: Z-3133-2026
Event ID: 99573
Recall initiated: Aug 5, 2026
Classified: Sep 10, 2026
Reported: Sep 16, 2026
Quantity: 3,286 cases
Distribution: 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.
Initiated by: Voluntary: Firm initiated
Firm notification: Letter
Firm location: Lewisberry, PA, United States
Lot / code info: BC-100 - Lot:N4L022 (exp.11/13/2026), N4L037(exp.11/18/2026) BC+201- Lot: N4L010(exp.11/06/2026)