Class IIDeviceOngoing

Nipro Renal Soultions USA, Corporation

Citric Complete Dry Citric Acid Concentrate REF: DCA+200-25 & DCA+203-25

Reason for recall

Hemodialysis concentrates contain high endotoxin levels

Details

Recall number: Z-3135-2026
Event ID: 99573
Recall initiated: Aug 5, 2026
Classified: Sep 10, 2026
Reported: Sep 16, 2026
Quantity: 7,770 cases
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.
Initiated by: Voluntary: Firm initiated
Firm notification: Letter
Firm location: Lewisberry, PA, United States
Lot / code info: 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)