Nipro Citric Complete Dry Citric Acid Concentrate Recalled for High Endotoxin Levels
Nipro Renal Solutions is recalling Citric Complete Dry Citric Acid Concentrate due to high endotoxin levels. The product is used in hemodialysis.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. The presence of high endotoxin levels in hemodialysis concentrates poses a significant risk of serious injury, meeting the criteria for a Severe rating.
Plain-English summary
Nipro Renal Solutions USA, Corporation is recalling 7,770 cases of Citric Complete Dry Citric Acid Concentrate (REF: DCA+200-25 & DCA+203-25). The recall was initiated because the hemodialysis concentrate contains high endotoxin levels.
The affected product was distributed nationwide in the United States in the states of FL, GA, IL, MD, MI, NC, NJ, NV, OH, and PA, as well as in Guatemala and Panama. Specific lot numbers and expiration dates are listed in the recall documentation.
Healthcare facilities and consumers should stop using the affected product and contact Nipro Renal Solutions for instructions on how to return it.
The recalled product
- Product
- Citric Complete Dry Citric Acid Concentrate REF: DCA+200-25 & DCA+203-25
- Manufacturer
- Nipro Renal Soultions USA, Corporation
- Hazard
- Affected units
- 7,770
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- 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
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