Z-0992-2026 Class II Ongoing

Recalled by Diasol, Inc — Phoenix, AZ

Recall Details

Product Type
Devices
Report Date
December 31, 2025
Initiation Date
November 5, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2200 gallons

Product Description

Brand Name: Diasol Product Name: 100425-10-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

Distribution Pattern

US Nationwide distribution in the states of MO, CA, AZ, TX, IL, MA.

Code Information

UDI: None/Lot Code: PHV08042