Nipro Renal Soultions USA, Corporation: Citric Complete Dry Citric Acid Concentrate REF: DCA+200-25 & DCA+203-25
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Nipro Renal Soultions USA, Corporation
- Product
- Citric Complete Dry Citric Acid Concentrate REF: DCA+200-25 & DCA+203-25
- Reason / hazard
- Hemodialysis concentrates contain high endotoxin levels
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- 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 initiated
- 2026-08-05
- 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)
- Product quantity
- 7,770 cases
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Lewisberry
- State
- PA
- Country
- United States
- Event id
- 99573
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