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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

DELFLEX Peritoneal Dialysis Solution Recalled for Tubing Leaks

Agency Publication Date: July 17, 2024
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Summary

Fresenius Medical Care Holdings, Inc. is recalling 183 cases of DELFLEX Peritoneal Dialysis Solution with Low Magnesium / Low Calcium 4.25% Dextrose. The product is packaged in a 2500mL single-dose container and includes an attached stay "safe Exchange Set. This recall was initiated because of a tube weld failure that can cause a slow leak that is difficult to detect. Consumers and healthcare providers should check their supply for the affected lot and stop using it immediately.

Risk

A failure in the tube weld can cause the solution to leak slowly, potentially compromising the sterility of the dialysis fluid. This defect could lead to serious infections, such as peritonitis, for patients undergoing peritoneal dialysis.

What You Should Do

  1. This recall affects DELFLEX Peritoneal Dialysis Solution with Low Magnesium / Low Calcium 4.25% Dextrose (NDC 49230-212-94) sold in 2500mL containers from lot 24AU03024 with an expiration date of 07/31/2025.
  2. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Fresenius Medical Care Holdings, Inc. at 1-800-323-5188 for further instructions.
  3. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have additional questions or wish to report an incident.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% DEXTROSE and attached stay "safe Exchange Set (2500mL)
Variants: 2500mL, 4.25% Dextrose, Single Dose Container
Lot Numbers:
24AU03024 (Exp 07/31/2025)
NDC:
49230-212-94

183 cases affected; For Intraperitoneal Administration Only

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94887
Status: Active
Manufacturer: Fresenius Medical Care Holdings, Inc.
Sold By: Authorized Medical Distributors; Dialysis Clinics
Manufactured In: United States
Units Affected: 183 cases
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.