FDA Medical Device Recalls (openFDA)
Nipro Renal Soultions USA, Corporation: Citric Complete - Dry Citric Acid Concentrate Model Number: DCA+225-25
- Recall number
- Z-0820-2025
- Recalling firm
- Nipro Renal Soultions USA, Corporation
- Product
- Citric Complete - Dry Citric Acid Concentrate Model Number: DCA+225-25
- Status
- Open, Classified
- Initiated
- 2024-11-22
- Posted
- 2025-01-08
- Terminated
- not on file
- Reason
- The outer case is mislabeled as 3.0 K, 2.0 Ca instead of 2.0 K, 3.0 Ca.
- 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 USorders@nipromed.com 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
- 2,810 units
- Distribution
- US distribution to states of: AZ, FL, GA, GA, IL, MI, NC, NJ, OH, TN, TX.
- Lot, serial or model codes
- Model Number: DCA+225-25. Lot Numbers: NDC4F001, NDC4G006, NDC4H009, NDC4H010.
- 510(k) numbers
- K171750
- PMA numbers
- not on file
- Product code
- KPO
- Firm FEI
- 1000142899
- Firm city
- Lewisberry
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28