FDA Medical devices recall ·
Citric Complete - Dry Citric Acid Concentrate Model Number: DCA+225-25 recall
- Recall number
- Z-0820-2025
- Date
- (initiated November 22, 2024)
- Company / brand
- Nipro Renal Soultions USA, Corporation
509 Fishing Creek Rd, Lewisberry, PA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 2,810 units
- Hazard tags
- Mislabeling
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Citric Complete - Dry Citric Acid Concentrate Model Number: DCA+225-25
Why was it recalled?
The outer case is mislabeled as 3.0 K, 2.0 Ca instead of 2.0 K, 3.0 Ca.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model Number: DCA+225-25. Lot Numbers: NDC4F001, NDC4G006, NDC4H009, NDC4H010.
Distribution
US distribution to states of: AZ, FL, GA, GA, IL, MI, NC, NJ, OH, TN, TX.
States: Arizona Florida Georgia Illinois Michigan North Carolina New Jersey Ohio Tennessee Texas
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0820-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.