Medical device recalls Moderate risk

Diasol, Inc recalls Brand Name: Diasol Product Name: 100325-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA…

Recall date
November 5, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0991-2026
FDA classification
Class II
Brand / firm
Diasol, Inc
Sold / distributed
US Nationwide distribution in the states of MO, CA, AZ, TX, IL, MA.

Why it was recalled

Safety and efficacy of dialysis acid concentrate cannot be assured

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Brand Name: Diasol Product Name: 100325-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters

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