Citric acid dialysis concentrate recalled for incorrect case labeling
Nipro Renal Solutions USA is recalling Citric Complete dry citric acid concentrate due to mislabeled outer cases that show incorrect potassium and calcium content values.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall involving mislabeling of electrolyte content on a dialysis product. While no illnesses or injuries have been reported, the labeling error on a product used in critical medical procedures presents a potential risk of harm if consumers rely on the incorrect case labeling.
Plain-English summary
Nipro Renal Solutions USA, Corporation is recalling Citric Complete - Dry Citric Acid Concentrate, Model Number DCA+225-25. The recall affects 2,810 units distributed to states including Arizona, Florida, Georgia, Illinois, Michigan, North Carolina, New Jersey, Ohio, Tennessee, and Texas.
The product's outer case labeling is incorrect. Cases are labeled as 3.0 K (potassium), 2.0 Ca (calcium) when they should be labeled as 2.0 K, 3.0 Ca. This labeling error could create confusion about the product's electrolyte composition.
The affected lot numbers are NDC4F001, NDC4G006, NDC4H009, and NDC4H010. Consumers who have received this product should verify the labeling and contact the manufacturer if they have questions about the correct product specifications.
The recalled product
- Product
- Citric Complete - Dry Citric Acid Concentrate Model Number: DCA+225-25
- Manufacturer
- Nipro Renal Soultions USA, Corporation
- Affected units
- 2,810
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 (4)
- Model Number: DCA+225-25. Lot Numbers: NDC4F001
- NDC4G006
- NDC4H009
- NDC4H010.
Distribution
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