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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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High RiskFDA Drug
Medications & Supplements/Prescription Drugs

Baxter Healthcare Corporation: Peritoneal Dialysis Solution Recalled for Tubing Leaks and Sterility Risks

Agency Publication Date: January 8, 2019
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Summary

Baxter Healthcare Corporation is recalling 29,370 bags of Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose. This recall was initiated because of confirmed customer complaints regarding leaks in the tubing of the 2000 mL UltraBag container bags. These leaks compromise the sterile environment required for the medication, which can lead to serious infections for patients using the solution for dialysis.

Risk

A leak in the dialysis tubing creates a pathway for environmental contaminants and bacteria to enter the solution. Because this fluid is introduced directly into the abdominal cavity during peritoneal dialysis, a lack of sterility poses a significant risk of peritonitis or other life-threatening infections.

What You Should Do

  1. Check your supply for Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose in 2000 mL UltraBag containers (Product Code 5B9766, NDC 0941-0424-52).
  2. Verify the lot number and expiration date on the packaging to see if it matches Lot #: Y281477 with an Expiry of 02/2020.
  3. If you identify an affected product, contact your healthcare provider or pharmacist immediately for guidance on alternative treatment and to report the issue.
  4. Return any unused, affected product to the pharmacy or place of purchase for a refund and contact Baxter Healthcare Corporation for further instructions.
  5. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

๐Ÿ’ฐFull Refund

Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose (2000 mL UltraBag)
Model:
Product Code 5B9766
NDC 0941-0424-52
Lot Numbers:
Y281477 (Exp 02/2020)
Date Ranges: February 2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 81881
Status: Resolved
Manufacturer: Baxter Healthcare Corporation
Sold By: Wholesalers; Distributors; Healthcare Facilities; Home Patients
Manufactured In: United States
Units Affected: 29,370 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.