Device recall
MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201
- Recall number
- Z-3133-2026
- Event id
- 99573
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Nipro Renal Soultions USA, Corporation
- Report date
- Sep 16, 2026
- Posted
- Sep 10, 2026
- Initiated
- Aug 5, 2026
- Center classification date
- Sep 10, 2026
- Product code
- KPO
- Device type
- Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
- Reason
- Hemodialysis concentrates contain high endotoxin levels
- Root cause
- Process control
- Quantity
- 3,286 cases
- Code info
- BC-100 - Lot:N4L022 (exp.11/13/2026), N4L037(exp.11/18/2026) BC+201- Lot: N4L010(exp.11/06/2026)
- 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.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K012547
- Location
- Lewisberry, PA, United States