Recall Z-0820-2025 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Nipro Renal Soultions USA, Corporation
Citric Complete - Dry Citric Acid Concentrate Model Number: DCA+225-25
| Date | Jan 8, 2025 (initiated Nov 22, 2024) |
| Status | Open, Classified |
| 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 question |
| Quantity | 2,810 units |
| Distribution | US distribution to states of: AZ, FL, GA, GA, IL, MI, NC, NJ, OH, TN, TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171750 | Citric Complete Dry Citric Acid (45X) Dimesol USA, LLC, Mar 6, 2018 |