FDA-Device2025-12-31Class IIPROCESSING DEFECT
Diasol dialysis acid concentrate recalled for safety and efficacy concerns
What this means
Diasol, Inc. is recalling a dialysis acid concentrate product because the safety and efficacy of the product cannot be assured. The recall affects 4,400 gallons of product distributed nationwide to medical facilities in Missouri, California, Arizona, Texas, Illinois, and Massachusetts.
- If you operate a dialysis facility, stop using affected lots PHV08112 and PHV10082 immediately.
- Contact Diasol, Inc. for guidance on product disposal and replacement options.
- Do not use the affected concentrate in patient dialysis treatments.
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
4400 gallons
Manufactured in
310 S 43rd Ave Ste B, N/A, Phoenix, AZ, United States
Products
Brand Name: Diasol Product Name: 100220-10-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-0989-2026Want us to check the next one for you?
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