Z-2402-2020Class II

Diasol 1000225-10-Dex100 Liquid Acid Concentrate for Bicarbonate Dialysis

Name: Z-2402-2020 Diasol 1000225-10-Dex100 Liquid Acid Concentrate for Bicarbonate Dialysis
Creator: Diasol, Inc
Published: 2020-04-30
License: https://open.fda.gov/license/

Diasol, Inc / initiated 2020-04-30 / Terminated / root cause: labeling and UDI

FDA source

Diasol, Inc began a recall of DIASOL 1000225-10-DEX100 LIQUID ACID CONCENTRATE FOR BICARBONATE DIALYSIS on 2020-04-30. FDA classified it as Class II and gives the reason as "Incorrect labeling of dialysate concentration for hemodialysis". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2402-2020
Classification: Class II
Status: Terminated
Initiated: 2020-04-30
Posted: 2020-06-18
Terminated: 2024-05-28
Recalling firm: Diasol, Inc
Product: Diasol 1000225-10-Dex100 Liquid Acid Concentrate for Bicarbonate Dialysis
Product code: KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Reason for recall: Incorrect labeling of dialysate concentration for hemodialysis.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: On 04/30/2020, the firm called customers informing them of the labeling error and instructed customers to: -Check if they have any remaining stock -Discontinue use of the specific lot -See if there have been any adverse events if used On 05/01/2020 the firm sent an "URGENT: MEDICAL DEVICE RECALL" to customers via certified mail informing them of the above and to contact customer service at (602) 442-7670 to arrange pickup of any stock of this lot number and replacement of a different lot number will be provided. For questions, contact Customer Service at (602) 442-7670.
Quantity in commerce: 212 Cases of 4 gallons each
Distribution: U.S.: CA O.U.S.:None
Product codes and lots: Model Number: 100225-10-DEX100 Gallons Unique Device Identifier (UDI): B467100225101004 and B4671000225101004 Lot codes if applicable: PHQ03041/030920

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2402-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2402-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-24	2020-06-18

Product code KPO

K851431Class IIHemodialysis Concentrate AdditivesDana Laboratories / cleared 1985-06-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)