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Open, Classified

Citric Complete - Dry Citric Acid Concentrate Model Number: DCA+225-25

FDA Recall Z-0820-2025 · Posted 2025-01-08

Recalling FirmNipro Renal Soultions USA, Corporation
Recall StatusOpen, Classified
Product CodeKPO
Date Initiated2024-11-22
Product Quantity2,810 units

Reason for Recall

The outer case is mislabeled as 3.0 K, 2.0 Ca instead of 2.0 K, 3.0 Ca.

Firm 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 [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.

Root Cause

Process control

Distribution Pattern

US distribution to states of: AZ, FL, GA, GA, IL, MI, NC, NJ, OH, TN, TX.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K171750Citric Complete Dry Citric Acid (45X)Dimesol USA, LLC · 2018-03-06

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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