FDA Medical devices recall ·
Diasol Product Name: 100225-10-DEX100, Liquid Concentrate for Bicarbonate… recall
- Recall number
- Z-0987-2026
- 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
- 186,000 containers
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Brand Name: Diasol Product Name: 100225-10-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: PHV07181 PHV07211 PHV07231 PHV07251 PHV07281 PHV07282 PHV07301 PHV07302 PHV07311 PHV08011 PHV08041 PHV08051 PHV08061 PHV08071 PHV08111 PHV08121 PHV08131 PHV08132 PHV08141 PHV08151 PHV08181 PHV08251 PHV08252 PHV09021 PHV09041 PHV09081 PHV09091 PHV09121 PHV09151 PHV09161 PHV09181 PHV09191 PHV09221 PHV09231 PHV09291 PHV10031 PHV10061 PHV10081 PHV10091 PHV10131
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-0987-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.