FDA Medical devices recall ·
Diasol Product Name: 100325-10-DEX100, Liquid Concentrate for Bicarbonate… recall
- Recall number
- Z-0991-2026
- Date
- (initiated November 5, 2025)
- Company / brand
- Diasol, Inc
310 S 43rd Ave Ste B, Phoenix, AZ, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 74,400 gallons
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Brand Name: Diasol Product Name: 100325-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Why was it recalled?
Safety and efficacy of dialysis acid concentrate cannot be assured
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI: None/Lot Code: PHV07221 PHV07241 PHV07291 PHV08182 PHV08201 PHV08221 PHV08271 PHV09031 PHV09051 PHV09101 PHV09111 PHV09152 PHV09171 PHV09241 PHV09251 PHV09261 PHV10071
Distribution
US Nationwide distribution in the states of MO, CA, AZ, TX, IL, MA.
States: Arizona California Illinois Massachusetts Missouri Texas
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0991-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.