Z-0992-2026 Class II Ongoing
FDA device recall Z-0992-2026 was initiated by Diasol, Inc on November 5, 2025 and is designated Class II. Reason for recall: Safety and efficacy of dialysis acid concentrate cannot be assured The recall status is ongoing. Affected quantity: 2200 gallons.
Recall Details
- Product Type
- Devices
- Report Date
- December 31, 2025
- Initiation Date
- November 5, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2200 gallons
Product Description
Brand Name: Diasol Product Name: 100425-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Reason for Recall
Safety and efficacy of dialysis acid concentrate cannot be assured
Distribution Pattern
US Nationwide distribution in the states of MO, CA, AZ, TX, IL, MA.
Code Information
UDI: None/Lot Code: PHV08042