Citric Complete - Dry Citric Acid Concentrate Model Number: DCA+225-25
This recall is currently active, issued January 8, 2025. It was issued by Nipro Renal Soultions Usa, Corporation.
- Recall Initiated
- November 22, 2024
- Posted
- January 8, 2025
- Recall Number
- Z-0820-2025
- Quantity
- 2,810 units
- Firm Location
- Lewisberry, PA
- Official Source
- View on FDA website ↗
Reason for Recall
The outer case is mislabeled as 3.0 K, 2.0 Ca instead of 2.0 K, 3.0 Ca.
Distribution
US distribution to states of: AZ, FL, GA, GA, IL, MI, NC, NJ, OH, TN, TX.
Lot / Code Info
Model Number: DCA+225-25. Lot Numbers: NDC4F001, NDC4G006, NDC4H009, NDC4H010.
Root Cause
Process control
Action Taken
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.