Device recall
Citric Complete Dry Citric Acid Concentrate REF: DCA+200-25 & DCA+203-25
- Recall number
- Z-3135-2026
- Event id
- 99573
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Nipro Renal Soultions USA, Corporation
- Report date
- Sep 16, 2026
- Posted
- Sep 10, 2026
- Initiated
- Aug 5, 2026
- Center classification date
- Sep 10, 2026
- Product code
- KPO
- Device type
- Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
- Reason
- Hemodialysis concentrates contain high endotoxin levels
- Root cause
- Process control
- Quantity
- 7,770 cases
- 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)
- 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.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K171750
- Location
- Lewisberry, PA, United States