FDA-Device2025-12-31Class IIPROCESSING DEFECT
Diasol dialysis acid concentrate recalled for unverified safety and efficacy
What this means
Diasol has recalled specific lots of its liquid concentrate used in bicarbonate dialysis machines. The FDA determined that the safety and efficacy of this product cannot be assured. The recall affects 7,200 gallons distributed across six states.
- Stop using product lot codes PHV08081 and PHV09042 immediately
- Contact your dialysis center or Diasol for instructions on obtaining safe replacement concentrate
- Do not use this concentrate in any dialysis machine
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
7,200 gallons
Manufactured in
310 S 43rd Ave Ste B, N/A, Phoenix, AZ, United States
Products
Brand Name: Diasol Product Name: 100125-10-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-0988-2026Want us to check the next one for you?
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