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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 Drug
Medications & Supplements/Prescription Drugs

Dianeal Peritoneal Dialysis Solution Recalled for Potential Sterile Leak

Agency Publication Date: July 6, 2024
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Summary

Baxter Healthcare Corporation has recalled 6,874 bags of Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose (6000 mL bags). This voluntary recall was issued because of potential leaks in the connector assembly component of the bags. These leaks could compromise the sterility of the dialysis solution, which is intended for intraperitoneal administration only.

Risk

Leaking components can allow bacteria or other environmental contaminants to enter the dialysis solution, leading to a loss of sterility. If a patient uses a contaminated solution during dialysis, there is a significant risk of developing peritonitis or other serious internal infections.

What You Should Do

  1. This recall affects Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, sold in 6000 mL bags (NDC 0941-0457-01).
  2. Check your supply for Lot R24B25FA with an expiration date of February 28, 2026.
  3. Stop using the recalled product immediately.
  4. Contact Baxter Healthcare Corporation or your medical distributor to arrange for the return of any unused bags.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for further information.

Your Remedy Options

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

Affected Products

Product: Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose (6000 mL)
Variants: 2.5% Dextrose, Low Calcium (2.5 mEq/L), 6000 mL bag
Lot Numbers:
R24B25FA (Exp. 2/28/2026)
NDC:
0941-0457-01

Recall #: D-0587-2024. Potential leaks in the Connector Assembly component.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94846
Status: Active
Manufacturer: Baxter Healthcare Corporation
Sold By: Hospitals; Dialysis Centers; Medical Distributors
Manufactured In: United States
Units Affected: 6,874 bags
Distributed To: Nationwide

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.