Diasol recalled 7,200 gallons of its 100125-10-DEX100 liquid concentrate on November 5, 2025. The recall affects dialysis patients in multiple states due to unassured safety and efficacy. Patients and healthcare providers must stop using this 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 100125-10-DEX100 liquid concentrate for bicarbonate dialysis. It was distributed nationwide in states including Missouri, California, Arizona, Texas, Illinois, and Massachusetts.
The safety and efficacy of the dialysis acid concentrate cannot be assured, posing a risk to patients relying on this treatment. The U.S. Food and Drug Administration classified this issue as a Class II recall, indicating a potential for temporary or medically reversible health consequences.
There are no specific reported incidents or injuries associated with this recall. However, the product's safety concerns warrant immediate action from users.
Patients and healthcare providers should stop using this product immediately. Contact Diasol, Inc or your healthcare provider for further instructions on returning the product and receiving a refund.
For more information, contact Diasol at the email provided in the recall notification. Additional details are available on the FDA's website.
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