Device recall
MedicaLyte Bicarbonate Powder REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X, 45X))
- Recall number
- Z-3134-2026
- 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
- 2,327 cases
- 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)
- 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
- K131202
- Location
- Lewisberry, PA, United States