Citric Complete - Dry Citric Acid Concentrate Model Number: DCA+225-25
Recall
- Recall Number
- Z-0820-2025
- Event Number
- 95878
- Firm
- Nipro Renal Soultions USA, Corporation
- FEI Number
- 1000142899
- Product Code
- KPO
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- November 22, 2024
- Posted
- January 8, 2025
- Address
- 509 Fishing Creek Rd, Lewisberry, PA, 17339-9517
Description
Citric Complete - Dry Citric Acid Concentrate Model Number: DCA+225-25
The outer case is mislabeled as 3.0 K, 2.0 Ca instead of 2.0 K, 3.0 Ca.
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.
US distribution to states of: AZ, FL, GA, GA, IL, MI, NC, NJ, OH, TN, TX.
2,810 units