Citric Complete Dry Citric Acid Concentrate REF: DCA+200-25 & DCA+203-25
Nipro Renal Soultions USA, Corporation · Hemodialysis concentrates contain high endotoxin levels
- Status
- Ongoing
- City
- Lewisberry
- State
- PA
- Country
- United States
- Classification
- Class II
- Product type
- Devices
- Event ID
- 99573
- Recalling firm
- Nipro Renal Soultions USA, Corporation
- Address 1
- 509 Fishing Creek Rd
- Postal code
- 17339-9517
- Voluntary mandated
- Voluntary: Firm initiated
- Initial firm notification
- Letter
- 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.
- Recall number
- Z-3135-2026
- Product description
- Citric Complete Dry Citric Acid Concentrate REF: DCA+200-25 & DCA+203-25
- Product quantity
- 7,770 cases
- Reason for recall
- Hemodialysis concentrates contain high endotoxin levels
- Recall initiation date
- 20260805
- Center classification date
- 20260910
- Report date
- 20260916
- 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)