HIGH

Diasol Recalls Dialysis Concentrate Over Safety Concerns

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.

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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About This Product

Diasol 100125-10-DEX100 is a liquid concentrate used in bicarbonate dialysis, a common treatment for patients with kidney failure. Patients buy this product to assist in their dialysis treatments, ensuring the proper balance of fluids and electrolytes in their bodies.

Why This Is Dangerous

The recall highlights concerns that the product may not perform effectively, which is critical for patients relying on dialysis for life-sustaining treatment. An ineffective concentrate could lead to serious health complications.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Patients who have used this dialysis concentrate may face health risks, making immediate cessation necessary. The recall impacts patient treatment plans and may require adjustments to ensure safe and effective dialysis.

Practical Guidance

How to identify if yours is affected

  1. Look for the product name 'Diasol 100125-10-DEX100' on the container.
  2. Check the lot codes PHV08081 or PHV09042 printed on the label.
  3. Confirm if you purchased the product between the specified distribution dates.

Where to find product info

Find the lot codes on the product label, typically near the expiration date or barcode.

What timeline to expect

Expect a refund process timeline of approximately 4-6 weeks after submitting your request.

If the manufacturer is unresponsive

  • Document your communication attempts with Diasol.
  • Consider filing a complaint with the FDA if no response is received.

How to prevent similar issues

  • Research the safety record of medical devices before purchasing.
  • Consult with healthcare providers regarding alternative products.
  • Review FDA recalls regularly to stay informed about medical device safety.

Documentation advice

Keep records of your purchase, including receipts and any communication with the manufacturer regarding the recall.

Product Details

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.

Key Facts

  • Recall date: November 5, 2025
  • Quantity recalled: 7,200 gallons
  • Distribution: Nationwide in the U.S.
  • Affected states: MO, CA, AZ, TX, IL, MA
  • Classification: Class II

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

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

Product Classification

Product Details

Brand
Model Numbers
UDI: None/Lot Code: PHV08081
PHV09042
Affected States
ALL
Report Date
December 31, 2025
Recall Status
ACTIVE

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