FDA-Device2025-12-31Class IIPROCESSING DEFECT
Diasol bicarbonate dialysis concentrate recalled over safety and efficacy concerns
What this means
Diasol is recalling specific lots of its bicarbonate dialysis liquid concentrate because the safety and efficacy of the product cannot be assured. The affected product was distributed nationwide to dialysis facilities in Missouri, California, Arizona, Texas, Illinois, and Massachusetts. No injuries have been reported.
- If you use Diasol dialysis concentrate, check if your lot code matches the recall list (PHV07181, PHV07211, PHV07231, and others ending in PHV10131)
- Contact your dialysis facility or Diasol, Inc. immediately if you have affected product
- Do not use affected lots
- Ask your healthcare provider about 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
186,000 containers
Manufactured in
310 S 43rd Ave Ste B, N/A, Phoenix, AZ, United States
Products
Brand Name: Diasol Product Name: 100225-10-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-0987-2026Want us to check the next one for you?
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