FDA recall Z-0992-2026

Diasol, Inc · Class II · device

Product

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

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

Key facts

Status
Ongoing
Initiation date
2025-11-05
Report date
2025-12-31
Voluntary/Mandated
Voluntary: Firm initiated
Location
Phoenix, AZ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0992-2026