HIGH

Diasol Recalls Dialysis Concentrate Over Safety Concerns

Diasol recalled 2,200 gallons of its 100425-10-DEX100 liquid concentrate for bicarbonate dialysis on November 5, 2025. The company cannot assure the safety and efficacy of the product. Patients and healthcare providers should stop using it immediately.

Quick Facts at a Glance

Recall Date
November 5, 2025
Hazard Level
HIGH
Brand
Diasol
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Safety and efficacy of dialysis acid concentrate cannot be assured

What You Should Do

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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Product Details

The recalled product is Diasol's 100425-10-DEX100 liquid concentrate for bicarbonate dialysis. It was distributed nationwide in states including Missouri, California, Arizona, Texas, Illinois, and Massachusetts.

The Hazard

The safety and efficacy of this dialysis acid concentrate cannot be assured. This poses a high hazard level for patients relying on this product for dialysis treatment.

Reported Incidents

No specific incidents were reported concerning this product. The recall was issued as a precautionary measure.

What to Do

Stop using the product immediately. Contact Diasol, Inc or your healthcare provider for further instructions.

Contact Information

For additional information, email Diasol, Inc or visit their official recall page at the FDA link provided.

Key Facts

  • 2200 gallons recalled
  • Safety and efficacy not assured
  • Immediate stop-use advised
  • Contact Diasol for instructions

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeLiquid Concentrate for Dialysis
Sold At
Multiple Retailers

Product Details

Brand
Model Numbers
UDI: None/Lot Code: PHV08042
Affected States
ALL
Report Date
December 31, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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