FDA-Device2025-12-31Class IIPROCESSING DEFECT
Diasol bicarbonate dialysis concentrate recalled for safety and efficacy concerns
OTHERNationwide distribution
Stop using Diasol dialysis concentrate
Diasol has recalled a bicarbonate dialysis liquid concentrate (product 100425-10-DEX100, lot PHV08042) because the FDA cannot confirm it is safe and effective for use. The recall affects approximately 2,200 gallons distributed across Missouri, California, Arizona, Texas, Illinois, and Massachusetts.
- Stop using this product immediately if you have it
- Contact your dialysis provider or healthcare facility for guidance
- Ask for a safe alternative dialysis concentrate
- Do not use this concentrate for dialysis treatment
Hazard
Safety and efficacy of dialysis acid concentrate cannot be assured
Sold states
US Nationwide distribution in the states of MO, CA, AZ, TX, IL, MA.
Affected count
2200 gallons
Manufactured in
310 S 43rd Ave Ste B, N/A, Phoenix, AZ, United States
Products
Brand Name: Diasol Product Name: 100425-10-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-0992-2026Don't want to check this manually?
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