Nipro Renal Soultions Usa, Corporation: Dialysate Concentrate For Hemodialysis (liquid Or Powder)

Recalling firm
Nipro Renal Soultions USA, Corporation
Product
Citric Complete Liquid Citric Acid Concentrate REF: LC+200-D,LC+201, LC+225(45X)
Reason
Hemodialysis concentrates contain high endotoxin levels
Classification
Class II
Category
medical device recall
Country
United States
Agency
FDA-DEVICES
Recall date
2026-08-05
Status
Open, Classified
Areas affected
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
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.

Official recall notice from FDA-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/b257f3f3-94c5-498a-8df1-ec889d8596b1