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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

Fresenius Medical Care, North America: Delflex Peritoneal Dialysis Solution Recalled for Labeling Mix-up

Agency Publication Date: May 19, 2021
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Summary

Fresenius Medical Care North America has recalled 709 cases of Delflex Peritoneal Dialysis Solution with 1.5% Dextrose because the boxes may actually contain bags of 4.25% Dextrose solution. This labeling mix-up means patients may unintentionally receive a much higher concentration of dextrose than prescribed. The affected product is packaged in cases containing two 6-liter bags and was distributed nationwide in the United States. No specific injuries were reported in the recall notice, but patients using this solution for dialysis should immediately verify their supplies.

Risk

Administering a dialysis solution with a higher dextrose concentration than intended can lead to serious health complications, such as dehydration or electrolyte imbalances, because the solution will pull more fluid from the patient's body than their treatment plan requires.

What You Should Do

  1. Check your medical supplies for Delflex Peritoneal Dialysis Solution with 1.5% Dextrose, LM/LC, in 6-liter bags (NDC 49230-206-60).
  2. Look for Lot #20SU03019 with an expiration date of 6/2022 printed on the packaging.
  3. Verify the bag inside the box: look specifically for any bags labeled as '4.25% DEXTROSE' that were found inside boxes labeled as '1.5% DEXTROSE'.
  4. If you have the affected lot, stop using it immediately and contact your healthcare provider or pharmacist for guidance on your dialysis treatment.
  5. Return any unused product from the affected lot to your pharmacy for a refund and contact Fresenius Medical Care North America for further instructions.
  6. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Contact healthcare provider and return product for refund.

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

Affected Products

Product: Delflex Peritoneal Dialysis Solution with 1.5% Dextrose, LM/LC (2 x 6 Liter bags)
Model:
NDC 49230-206-60
Recall #: D-0389-2021
Lot Numbers:
20SU03019 (Exp 6/2022)
Date Ranges: Exp 6/2022

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 87809
Status: Resolved
Manufacturer: Fresenius Medical Care, North America
Sold By: Authorized medical distributors; Pharmacies
Manufactured In: United States
Units Affected: 709 cases
Distributed To: Nationwide
Agency Last Updated: May 31, 2022

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.