Data Foundry

Medical device recalls 2020

DIASOL 1000225-10-DEX100 LIQUID ACID CONCENTRATE FOR BICARBONATE… — Class II medical device recall Z-2402-2020

Terminated recall by Diasol, Inc, reported 2020-06-24, distributed in CA. Incorrect labeling of dialysate concentration for hemodialysis.

Recall numberZ-2402-2020
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmDiasol, Inc, Phoenix, AZ, United States
Recall initiated2020-04-30
Classified2020-06-18
Reported by FDA2020-06-24
Terminated2024-05-28
DistributedCA
Reason classeslabeling
Model numbers100225-10-DEX100

Product

DIASOL 1000225-10-DEX100 LIQUID ACID CONCENTRATE FOR BICARBONATE DIALYSIS

Reason for recall

Incorrect labeling of dialysate concentration for hemodialysis.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2402-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.