FDA-Device2025-12-31Class IIPROCESSING DEFECT
Diasol bicarbonate dialysis concentrate recalled over unassured safety and efficacy
What this means
Diasol, Inc. is recalling specific lots of its 100230-10-DEX100 bicarbonate dialysis liquid concentrate because the safety and efficacy of the product cannot be assured. The affected product was distributed nationwide in Missouri, California, Arizona, Texas, Illinois, and Massachusetts. No injuries have been reported.
- Stop using Diasol product lot PHV07222 or PHV09082 immediately
- Contact your dialysis facility or healthcare provider right away
- Do not use this concentrate for dialysis treatments
- Ask your facility about using an alternative dialysis concentrate
The agency's original wording
Hazard
Safety and efficacy of dialysis acid concentrate cannot be assured
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of MO, CA, AZ, TX, IL, MA.
Affected count
4,400 gallons
Manufactured in
310 S 43rd Ave Ste B, N/A, Phoenix, AZ, United States
Products
Brand Name: Diasol Product Name: 100230-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0990-2026Want us to check the next one for you?
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