Dialysis concentrate Recall: Diasol PHV07222/PHV09082
Announced 2025-12-31 · FDA
The FDA recalls a Diasol brand liquid concentrate for bicarbonate dialysis because the safety and efficacy of the product cannot be assured. About 4,400 gallons were distributed nationwide in MO, CA, AZ, TX, IL, and MA. Affected lots are PHV07222 and PHV09082 (UDI: None/Lot Code: PHV07222,PHV09082).
| Brand | Diasol, Inc |
|---|---|
| Product | Brand Name: Diasol Product Name: 100230-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters |
| Reason | Safety and efficacy of dialysis acid concentrate cannot be assured |
| Severity | moderate |
| Units affected | 2200 |
| Distribution | US Nationwide distribution in the states of MO, CA, AZ, TX, IL, MA. |
| Agency | FDA |
| Recall / campaign no. | UDI: None/Lot Code: PHV07222,PHV09082 |
WHAT YOU SHOULD DO
- Do not use any Diasol dialysis concentrate from lots PHV07222 or PHV09082.
- Quarantine the product and keep it separated from usable supplies.
- Contact your dialysis provider or the product supplier for disposal, return, or replacement instructions.
- If you are undergoing dialysis and have concerns, consult your clinician.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.