Recall Z-2402-2020— Diasol, Inc

Name: FDA recall Z-2402-2020
Creator: U.S. Food and Drug Administration
Published: 2020-04-30

Class II · Terminated

Class II FDA medical device recall by Diasol, Inc, initiated 2020-04-30, terminated 2024-05-28. It names one FDA 510(k) clearance: K851431. Product: DIASOL 1000225-10-DEX100 LIQUID ACID CONCENTRATE FOR BICARBONATE DIALYSIS. Reason: Incorrect labeling of dialysate concentration for hemodialysis..

Recalling firm: Diasol, Inc
Classification: Class II
Status: Terminated
Initiated: 2020-04-30
Terminated: 2024-05-28
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 1000225-10-DEX100 LIQUID ACID CONCENTRATE FOR BICARBONATE DIALYSIS

Reason for recall

Incorrect labeling of dialysate concentration for hemodialysis.

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