Z-3133-2026 Class II Ongoing
FDA device recall Z-3133-2026 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: 3,286 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
- 3,286 cases
Product Description
MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201
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
BC-100 - Lot:N4L022 (exp.11/13/2026), N4L037(exp.11/18/2026) BC+201- Lot: N4L010(exp.11/06/2026)