Recall Z-0207-2025— Diasol, Inc

Name: FDA recall Z-0207-2025
Creator: U.S. Food and Drug Administration
Published: 2022-07-27

Class II · Ongoing

Class II FDA medical device recall by Diasol, Inc, initiated 2022-07-27. It names one FDA 510(k) clearance: K851431. Product: Diasol Acid Concentrate REF G100325-10Dex 100. Reason: Due to labeling issue. The box label is different that the gallon label in that gallon label shows a lower Calcium concentration than the box label..

Recalling firm: Diasol, Inc
Classification: Class II
Status: Ongoing
Initiated: 2022-07-27
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

Diasol Acid Concentrate REF G100325-10Dex 100

Reason for recall

Due to labeling issue. The box label is different that the gallon label in that gallon label shows a lower Calcium concentration than the box label.

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