Citric Complete - Dry Citric Acid Concentrate Model Number: DCA+225-25
Summary
The FDA issued a Class II for Citric Complete - Dry Citric Acid Concentrate Model Number: DCA+225-25 by Nipro Renal Soultions USA, Corporation. Reason: The outer case is mislabeled as 3.0 K, 2.0 Ca instead of 2.0 K, 3.0 Ca..
Details
Source
Device Recall
External ID
Z-0820-2025
Action Date
2025-01-15
Status
Ongoing
Category
device
Product Description
Citric Complete - Dry Citric Acid Concentrate Model Number: DCA+225-25
Lot/Code Info: Model Number: DCA+225-25. Lot Numbers: NDC4F001, NDC4G006, NDC4H009, NDC4H010.
Quantity Affected: 2,810 units
Reason for Recall
The outer case is mislabeled as 3.0 K, 2.0 Ca instead of 2.0 K, 3.0 Ca.
Distribution
US distribution to states of: AZ, FL, GA, GA, IL, MI, NC, NJ, OH, TN, TX.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-11-22
Company
Lewisberry, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 137 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Nipro Renal Soultions USA, Corporation has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Nipro Renal Soultions USA, Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Nipro Renal Soultions USA, Corporation have FDA actions?
Nipro Renal Soultions USA, Corporation has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0820-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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