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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices

Diasol Dialysis Acid Concentrates Recalled for Safety and Efficacy Concerns

Agency Publication Date: December 23, 2025
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Summary

Diasol, Inc. is recalling approximately 278,600 units of Diasol Liquid Concentrate for Bicarbonate Dialysis because the manufacturer cannot assure the safety or effectiveness of the product. These acid concentrates are used in hospitals and clinics to perform dialysis treatments for patients with kidney failure. The recall was voluntarily initiated by the firm after determining that the quality of the concentrate could not be guaranteed.

Risk

If the safety and efficacy of these dialysis concentrates are compromised, patients may receive treatment with incorrect electrolyte levels or contaminated fluids. This could lead to serious health complications, such as electrolyte imbalances or infections during the dialysis process.

What You Should Do

  1. This recall affects various formulations of Diasol Liquid Concentrate for Bicarbonate Dialysis, including product numbers 100225-10-DEX100, 100125-10-DEX100, 100220-10-DEX100, 100230-10-DEX100, 100325-10-DEX100, and 100425-10-DEX100.
  2. Check the lot number printed on the container label. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled product immediately.
  4. Contact Diasol, Inc. directly or your medical supply distributor to arrange for the return, replacement, or correction of the affected units.
  5. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional consumer safety information.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Diasol 100225-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis (208.2 liters)
Variants: Non Pyrogenic, 2K, 3.0CA, 1.0MG
Model / REF:
100225-10-DEX100
Lot Numbers:
PHV07181
PHV07211
PHV07231
PHV07251
PHV07281
PHV07282
PHV07301
PHV07302
PHV07311
PHV08011
PHV08041
PHV08051
PHV08061
PHV08071
PHV08111
PHV08121
PHV08131
PHV08132
PHV08141
PHV08151
PHV08181
PHV08251
PHV08252
PHV09021
PHV09041
PHV09081
PHV09091
PHV09121
PHV09151
PHV09161
PHV09181
PHV09191
PHV09221
PHV09231
PHV09291
PHV10031
PHV10061
PHV10081
PHV10091
PHV10131

Quantity: 186,000 containers; Recall #: Z-0987-2026

Product: Diasol 100125-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis (208.2 liters)
Variants: Non Pyrogenic, 2K, 3.0CA, 1.0MG
Model / REF:
100125-10-DEX100
Lot Numbers:
PHV08081
PHV09042

Quantity: 7,200 gallons; Recall #: Z-0988-2026

Product: Diasol 100220-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis (208.2 liters)
Variants: Non Pyrogenic, 2K, 3.0CA, 1.0MG
Model / REF:
100220-10-DEX100
Lot Numbers:
PHV08112
PHV10082

Quantity: 4,400 gallons; Recall #: Z-0989-2026

Product: Diasol 100230-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis (208.2 liters)
Variants: Non Pyrogenic, 2K, 3.0CA, 1.0MG
Model / REF:
100230-10-DEX100
Lot Numbers:
PHV07222
PHV09082

Quantity: 4,400 gallons; Recall #: Z-0990-2026

Product: Diasol 100325-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis (208.2 liters)
Variants: Non Pyrogenic, 2K, 3.0CA, 1.0MG
Model / REF:
100325-10-DEX100
Lot Numbers:
PHV07221
PHV07241
PHV07291
PHV08182
PHV08201
PHV08221
PHV08271
PHV09031
PHV09051
PHV09101
PHV09111
PHV09152
PHV09171
PHV09241
PHV09251
PHV09261
PHV10071

Quantity: 74,400 gallons; Recall #: Z-0991-2026

Product: Diasol 100425-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis (208.2 liters)
Variants: Non Pyrogenic, 2K, 3.0CA, 1.0MG
Model / REF:
100425-10-DEX100
Lot Numbers:
PHV08042

Quantity: 2,200 gallons; Recall #: Z-0992-2026

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97989
Status: Active
Manufacturer: Diasol, Inc
Sold By: Hospitals; Dialysis Clinics; Medical Equipment Distributors
Manufactured In: United States
Units Affected: 6 products (186,000 containers; 7,200 gallons; 4400 gallons; 4,400 gallons; 74,400 gallons; 2200 gallons)
Distributed To: Missouri, California, Arizona, Texas, Illinois, Massachusetts

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.