Citric Complete - Dry Citric Acid Concentrate Model Number: DCA+225-25
FDA device recall Z-0820-2025 · posted 2025-01-08 · Open, Classified
Recall details
- Recalling firm
- Nipro Renal Soultions USA, Corporation
- Reason for recall
- The outer case is mislabeled as 3.0 K, 2.0 Ca instead of 2.0 K, 3.0 Ca.
- 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.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- KPO
- Quantity affected
- 2,810 units
- Distribution
- US distribution to states of: AZ, FL, GA, GA, IL, MI, NC, NJ, OH, TN, TX.
- Date initiated
- 2024-11-22
- Date posted
- 2025-01-08
- Location
- Lewisberry, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Citric Complete Dry Citric Acid (45X) (K171750) | Dimesol USA, LLC | 2018-03-06 |