Class IIReported 2025-12-31

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

Reason for Recall

Safety and efficacy of dialysis acid concentrate cannot be assured

Recall Number

Z-0987-2026

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: PHV07181 PHV07211 PHV07231 PHV07251 PHV07281 PHV07282 PHV07301 PHV07302 PHV07311 PHV08011 PHV08041 PHV08051 PHV08061 PHV08071 PHV08111 PHV08121 PHV08131 PHV08132 PHV08141 PHV08151 PHV08181 PHV08251 PHV08252 PHV09021 PHV09041 PHV09081 PHV09091 PHV09121 PHV09151 PHV09161 PHV09181 PHV09191 PHV09221 PHV09231 PHV09291 PHV10031 PHV10061 PHV10081 PHV10091 PHV10131

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