PlainRecalls
FDA Devices Moderate Class II Ongoing

Brand Name: Diasol Product Name: 100225-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters

Reported: December 31, 2025 Initiated: November 5, 2025 #Z-0987-2026

Product Description

Brand Name: Diasol Product Name: 100225-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters

Reason for Recall

Safety and efficacy of dialysis acid concentrate cannot be assured

Details

Recalling Firm
Diasol, Inc
Units Affected
186,000 containers
Distribution
US Nationwide distribution in the states of MO, CA, AZ, TX, IL, MA.
Location
Phoenix, AZ

Frequently Asked Questions

What product was recalled?
Brand Name: Diasol Product Name: 100225-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters. Recalled by Diasol, Inc. Units affected: 186,000 containers.
Why was this product recalled?
Safety and efficacy of dialysis acid concentrate cannot be assured
Which agency issued this recall?
This recall was issued by the FDA Devices on December 31, 2025. Severity: Moderate. Recall number: Z-0987-2026.