Device recall enforcement reports

Citric Complete Liquid Citric Acid Concentrate REF: LC+200-D,LC+201, LC+225(45X)

Nipro Renal Soultions USA, Corporation · Hemodialysis concentrates contain high endotoxin levels

Class IIOngoingZ-3136-2026
Status
Ongoing
City
Lewisberry
State
PA
Country
United States
Classification
Class II
Product type
Devices
Event ID
99573
Recalling firm
Nipro Renal Soultions USA, Corporation
Address 1
509 Fishing Creek Rd
Postal code
17339-9517
Voluntary mandated
Voluntary: Firm initiated
Initial firm notification
Letter
Distribution pattern
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.
Recall number
Z-3136-2026
Product description
Citric Complete Liquid Citric Acid Concentrate REF: LC+200-D,LC+201, LC+225(45X)
Product quantity
100 drums/1072 cases
Reason for recall
Hemodialysis concentrates contain high endotoxin levels
Recall initiation date
20260805
Center classification date
20260910
Report date
20260916
Code info
LC+200-D: Lot-N4J030 (Exp.9/20/2026), N5D043(Exp.4/16/2027); LC+225: Lot-N6A025(Exp.1/8/2028)
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.