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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

DELFLEX Peritoneal Dialysis Solution Recalled for Lack of Sterility Assurance

Agency Publication Date: January 5, 2024
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Summary

Fresenius Medical Care Holdings, Inc. is recalling 69,590 bags of DELFLEX Peritoneal Dialysis Solution (1.5% Dextrose) due to a lack of sterility assurance. The recalled product is a prescription medication packaged in 6000mL Biofine containers. No incidents or injuries have been reported to date in connection with this recall.

Risk

A lack of sterility assurance means the solution could be contaminated with microorganisms. If contaminated solution is used during dialysis, it may cause serious infections such as peritonitis, which is an inflammation of the lining of the abdominal cavity.

What You Should Do

  1. This recall affects DELFLEX Peritoneal Dialysis Solution (1.5% Dextrose) in 6000mL Biofine containers with NDC 49230-206-62, part number 077-60621, and lot number 23JK02010 (Expiration Date 1/31/2025).
  2. Stop using the recalled product immediately.
  3. Contact Fresenius Medical Care Holdings, Inc. or your medical supply distributor to arrange for the return of any remaining product.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional 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: DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose (6000mL)
Variants: 1.5% Dextrose, 6000mL bags
Model:
077-60621
Lot Numbers:
23JK02010 (Exp 1/31/2025)
NDC:
49230-206-62

Rx only

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93690
Status: Active
Manufacturer: Fresenius Medical Care Holdings, Inc.
Sold By: Fresenius Medical Care NA
Manufactured In: United States
Units Affected: 69,590 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.