Z-0992-2026Class II

Brand Name: Diasol Product Name: 100425-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic...

Name: Z-0992-2026 Brand Name: Diasol Product Name: 100425-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic...
Creator: Diasol, Inc
Published: 2025-11-05
License: https://open.fda.gov/license/

Diasol, Inc / initiated 2025-11-05 / Open, Classified / root cause: manufacturing process

FDA source

Diasol, Inc began a recall of Brand Name: Diasol Product Name: 100425-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters on 2025-11-05. FDA classified it as Class II and gives the reason as "Safety and efficacy of dialysis acid concentrate cannot be assured". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0992-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-11-05
Posted: 2025-12-23
Recalling firm: Diasol, Inc
Product: Brand Name: Diasol Product Name: 100425-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Product code: KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Reason for recall: Safety and efficacy of dialysis acid concentrate cannot be assured
Root cause tag: manufacturing process
FDA root cause: Process design
Action: On November 5, 2025, Diasol issued a "Urgent Medical Device Recall Notification to affected consignees. In addition to informing consignees about the recall, Diasol asked consignees to take the following actions: 1. Please return all product you have at your facility. 2. Please complete the attached acknowledgement form. 3. If product has been further distributed to other distributors, customer or sites, notify those consignees and provide them with a copy of the recall notification. 4. The notice should be provided to all staff members who use the product. 5. In the event you have not received adequate products from Rockwell you may continue to use Diasol Products at risk.
Quantity in commerce: 2200 gallons
Distribution: US Nationwide distribution in the states of MO, CA, AZ, TX, IL, MA.
Product codes and lots: UDI: None/Lot Code: PHV08042

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0992-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0987-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-31	2025-12-23
Z-0988-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-31	2025-12-23
Z-0989-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-31	2025-12-23
Z-0990-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-31	2025-12-23
Z-0991-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-31	2025-12-23
Z-0992-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-31	2025-12-23

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)