Class II
Medical Device Recall: Brand Name: Diasol Product Name: 100225-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Diasol, Inc · November 5, 2025
Reason for Recall
Safety and efficacy of dialysis acid concentrate cannot be assured
Distribution
US Nationwide distribution in the states of MO, CA, AZ, TX, IL, MA.
States Affected
NATIONWIDE
Quantity Affected
186,000 containers
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0987-2026
Status: ongoing
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