Recall Z-0820-2025— Nipro Renal Soultions USA, Corporation
Class II · Ongoing
Class II FDA medical device recall by Nipro Renal Soultions USA, Corporation, initiated 2024-11-22. It names one FDA 510(k) clearance: K171750. Product: Citric Complete - Dry Citric Acid Concentrate Model Number: DCA+225-25. Reason: The outer case is mislabeled as 3.0 K, 2.0 Ca instead of 2.0 K, 3.0 Ca..
- Recalling firm
- Nipro Renal Soultions USA, Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-11-22
- Firm location
- Lewisberry, PA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Citric Complete - Dry Citric Acid Concentrate Model Number: DCA+225-25
Reason for recall
The outer case is mislabeled as 3.0 K, 2.0 Ca instead of 2.0 K, 3.0 Ca.
Data sourced from openFDA. This site is unofficial and independent of the FDA.