Z-0991-2026 Class II Ongoing
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
- 74,400 gallons
Product Description
Brand Name: Diasol Product Name: 100325-10-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: PHV07221 PHV07241 PHV07291 PHV08182 PHV08201 PHV08221 PHV08271 PHV09031 PHV09051 PHV09101 PHV09111 PHV09152 PHV09171 PHV09241 PHV09251 PHV09261 PHV10071