Diasol, Inc recalls Brand Name: Diasol Product Name: 100225-10-DEX100

Safety and efficacy of dialysis acid concentrate cannot be assured

Brand Name: Diasol Product Name: 100225-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters

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.

• FDA enforcement recordOfficial FDA database entry for Z-0987-2026
• FDA 510(k) clearance · K851431The device's official FDA premarket clearance record
• FDA device classification · KPOOfficial FDA classification for this device type
• CFR regulation · 21 CFR 876.5820The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Diasol, IncSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.