Z-3134-2026 Class II Ongoing
FDA device recall Z-3134-2026 was initiated by Nipro Renal Soultions USA, Corporation on August 5, 2026 and is designated Class II. Reason for recall: Hemodialysis concentrates contain high endotoxin levels The recall status is ongoing. Affected quantity: 2,327 cases.
Recall Details
- Product Type
- Devices
- Report Date
- September 16, 2026
- Initiation Date
- August 5, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,327 cases
Product Description
MedicaLyte Bicarbonate Powder REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X, 45X))
Reason for Recall
Hemodialysis concentrates contain high endotoxin levels
Distribution Pattern
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.
Code Information
DB+201-2.1: Lot -NDB5E004(exp.4/30/2027) DB+201-25: Lots - NDB5M011(Exp.12/05/2027, NDB4J003(exp.9/25/2026)