Recall Z-0987-2026— Diasol, Inc

Name: FDA recall Z-0987-2026
Creator: U.S. Food and Drug Administration
Published: 2025-11-05

Class II · Ongoing

Class II FDA medical device recall by Diasol, Inc, initiated 2025-11-05. It names one FDA 510(k) clearance: K851431. Product: Brand Name: Diasol Product Name: 100225-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters. Reason: Safety and efficacy of dialysis acid concentrate cannot be assured.

Recalling firm: Diasol, Inc
Classification: Class II
Status: Ongoing
Initiated: 2025-11-05
Firm location: Phoenix, AZ, United States

510(k) clearances named in this recall

1 on FDA's record

K851431 — HEMODIALYSIS CONCENTRATE ADDITIVESDana Laboratories·cleared 1985-06-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.