Brand Name: Diasol Product Name: 100325-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
FDA Recall Z-0991-2026 · Posted 2025-12-23
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Recalling FirmDiasol, Inc
Recall StatusOpen, Classified
Product CodeKPO
Date Initiated2025-11-05
Product Quantity74,400 gallons
Reason for Recall
Safety and efficacy of dialysis acid concentrate cannot be assured
Firm 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.
Root Cause
Process design
Distribution Pattern
US Nationwide distribution in the states of MO, CA, AZ, TX, IL, MA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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