FDA-Device2025-12-31Class IIPROCESSING DEFECT
Brand Name: Diasol Product Name: 100325-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Hazard
Safety and efficacy of dialysis acid concentrate cannot be assured
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of MO, CA, AZ, TX, IL, MA.
Affected count
74,400 gallons
Manufactured in
310 S 43rd Ave Ste B, N/A, Phoenix, AZ, United States
Products
Brand Name: Diasol Product Name: 100325-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0991-2026Want us to check the next one for you?
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