Diasol recalled 74,400 gallons of its Liquid Concentrate for Bicarbonate Dialysis on November 5, 2025. The recall stems from concerns about the safety and efficacy of the dialysis acid concentrate. Patients and healthcare providers should stop using the product immediately.
Safety and efficacy of dialysis acid concentrate cannot be assured
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Diasol, Inc or your healthcare provider for instructions. Notification method: E-Mail
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The recalled product is Diasol's Liquid Concentrate for Bicarbonate Dialysis, model number 100325-10-DEX100. It has been distributed nationwide in states including MO, CA, AZ, TX, IL, and MA.
The safety and efficacy of this dialysis acid concentrate cannot be assured. This poses a significant risk to patients relying on dialysis treatment.
No specific incidents have been reported, but the recall indicates a high level of risk associated with its use.
Stop using the product immediately. Follow the recall instructions provided by Diasol. Contact Diasol or your healthcare provider for further guidance.
For more information, call Diasol, Inc. or visit their website. Further details are available at the FDA's recall page.
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