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Recall Observatory FDA recall evidence

Device product

Citric Complete - Dry Citric Acid Concentrate Model Number: DCA+225-25

Z-0820-2025

November 22, 2024

Class II

Product summary

Firm
Nipro Renal Soultions USA, Corporation
Event
Event 95878
Status
Ongoing
Classification
Class II
Quantity
2,810 units
Official record key
device-enforcement:Z-0820-2025

Official wording

Reason: The outer case is mislabeled as 3.0 K, 2.0 Ca instead of 2.0 K, 3.0 Ca.

Code information: Model Number: DCA+225-25. Lot Numbers: NDC4F001, NDC4G006, NDC4H009, NDC4H010.

Distribution pattern: US distribution to states of: AZ, FL, GA, GA, IL, MI, NC, NJ, OH, TN, TX.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    mislabeled