FDA Medical devices recall ·
Diasol Product Name: 100220-10-DEX100, Liquid Concentrate for Bicarbonate… recall
- Recall number
- Z-0989-2026
- 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
- 4400 gallons
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Brand Name: Diasol Product Name: 100220-10-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: PHV08112,PHV10082
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-0989-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.