Class IIReported 2025-12-31

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

Recalled by Diasol, Inc

Reason for Recall

Safety and efficacy of dialysis acid concentrate cannot be assured

Recall Number

Z-0991-2026

Classification

Class II

Status

Ongoing

Category

device

Initiated

2025-11-05

Reported

2025-12-31

Distribution

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

Code Info

UDI: None/Lot Code: PHV07221 PHV07241 PHV07291 PHV08182 PHV08201 PHV08221 PHV08271 PHV09031 PHV09051 PHV09101 PHV09111 PHV09152 PHV09171 PHV09241 PHV09251 PHV09261 PHV10071

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.