Z-3136-2026 Class II Ongoing
FDA device recall Z-3136-2026 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: 100 drums/1072 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
- 100 drums/1072 cases
Product Description
Citric Complete Liquid Citric Acid Concentrate REF: LC+200-D,LC+201, LC+225(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
LC+200-D: Lot-N4J030 (Exp.9/20/2026), N5D043(Exp.4/16/2027); LC+225: Lot-N6A025(Exp.1/8/2028)