Z-0820-2025Class II

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

Name: Z-0820-2025 Citric Complete - Dry Citric Acid Concentrate Model Number: DCA+225-25
Creator: Nipro Renal Soultions USA, Corporation
Published: 2024-11-22
License: https://open.fda.gov/license/

Nipro Renal Solutions USA, Corporation / initiated 2024-11-22 / Open, Classified / root cause: manufacturing process

FDA source

Nipro Renal Soultions USA, Corporation began a recall of Citric Complete - Dry Citric Acid Concentrate Model Number: DCA+225-25 on 2024-11-22. FDA classified it as Class II and gives the reason as "The outer case is mislabeled as 3.0 K, 2.0 Ca instead of 2.0 K, 3.0 Ca". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0820-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-11-22
Posted: 2025-01-08
Recalling firm: Nipro Renal Solutions USA, Corporation
Product: Citric Complete - Dry Citric Acid Concentrate Model Number: DCA+225-25
Product code: KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Reason for recall: The outer case is mislabeled as 3.0 K, 2.0 Ca instead of 2.0 K, 3.0 Ca.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Nipro notified their distributor on 11/22/2024 via email. Direct customers were notified via email on 11/25/2024. The firm sent a "Medical Device Recall" letter dated 11/11/2024 to its customers. The letter instructed customers to place any affected units in inventory on hold and return them immediately. They were also instructed to complete the quantity in stock column on the attached response form and return to [email protected] for processing. Nipro Partner Solutions team will coordinate the return of all recalled products from your facility back to Nipro. If you have any questions, contact Director QA/RA at 717-938-8391.
Quantity in commerce: 2,810 units
Distribution: US distribution to states of: AZ, FL, GA, GA, IL, MI, NC, NJ, OH, TN, TX.
Product codes and lots: Model Number: DCA+225-25. Lot Numbers: NDC4F001, NDC4G006, NDC4H009, NDC4H010.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0820-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0820-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-15	2025-01-08

Product code KPO

K171750Class IICitric Complete Dry Citric Acid (45X)Dimesol USA, LLC / cleared 2018-03-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)