Nipro Renal Soultions USA, Corporation recalls 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 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.

• FDA enforcement recordOfficial FDA database entry for Z-0820-2025
• FDA 510(k) clearance · K171750The device's official FDA premarket clearance record
• FDA device classification · KPOOfficial FDA classification for this device type
• CFR regulation · 21 CFR 876.5820The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Nipro Renal Soultions USA, CorporationSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.