Z-3135-2026 Class II Ongoing
FDA device recall Z-3135-2026 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: 7,770 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
- 7,770 cases
Product Description
Citric Complete Dry Citric Acid Concentrate REF: DCA+200-25 & DCA+203-25
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
DCA+200-25 : Lots - NDC5E015(Exp.5/20/2027), NDC5E016(Exp.5/21/2027), NDC5E017(Exp.5/22/2027), NDC5E019(Exp.5/29/2027), NDC5E012(Exp.5/19/2027), NDC5B017(Exp.2/24/2027), NDC5C023(Exp.3/24/2027) DCA+203-25: NDC5C026(Exp.3/27/2027), NDC5L026(Exp.11/17/2027)