Citric Complete Liquid Citric Acid Concentrate REF: LC+200-D,LC+201, LC+225(45X)
Summary
The FDA issued a Class II for Citric Complete Liquid Citric Acid Concentrate REF: LC+200-D,LC+201, LC+225(4 by Nipro Renal Soultions USA, Corporation. Reason: Hemodialysis concentrates contain high endotoxin levels.
Details
Source
Device Recall
External ID
Z-3136-2026
Action Date
2026-09-16
Status
Ongoing
Category
device
Product Description
Citric Complete Liquid Citric Acid Concentrate REF: LC+200-D,LC+201, LC+225(45X)
Lot/Code Info: LC+200-D: Lot-N4J030 (Exp.9/20/2026), N5D043(Exp.4/16/2027); LC+225: Lot-N6A025(Exp.1/8/2028)
Quantity Affected: 100 drums/1072 cases
Reason for Recall
Hemodialysis concentrates contain high endotoxin levels
Distribution
Worldwide - US Nationwide distribution in the states of FL, GA, IL, MD, MI, NC, NJ, NV, OH, PA, and the countries of Guatemala and Panama.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-08-05
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 180 device recalls issued in the same week, part of 445 device-related FDA actions this month.
Nipro Renal Soultions USA, Corporation has 6 FDA actions in our database, including 6 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 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3136-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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