Device recall
Citric Complete Liquid Citric Acid Concentrate REF: LC+200-D,LC+201, LC+225(45X)
- Recall number
- Z-3136-2026
- 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
- 100 drums/1072 cases
- Code info
- LC+200-D: Lot-N4J030 (Exp.9/20/2026), N5D043(Exp.4/16/2027); LC+225: Lot-N6A025(Exp.1/8/2028)
- 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
- K223431
- Location
- Lewisberry, PA, United States