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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 Renal Therapies Group, LLC: DELFLEX Peritoneal Dialysis Solution Recalled for Potential Sterility Issues

Agency Publication Date: March 20, 2018
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Summary

Approximately 3,734 cases of DELFLEX Peritoneal Dialysis Solution (2.5% Low Mg/Low Ca Single Bag) have been recalled because the solution bags may leak. This leakage can compromise the sterility of the medical fluid used for dialysis treatments. Consumers should contact their healthcare provider or pharmacist immediately regarding this recall of 3-liter and 2-liter packs.

Risk

A leaking bag can allow bacteria or other contaminants to enter the dialysis solution, posing a serious risk of infection to patients. Because this solution is introduced directly into the peritoneal cavity during dialysis, a lack of sterility could lead to peritonitis or other severe health complications.

What You Should Do

  1. Check your DELFLEX Peritoneal Dialysis Solution packaging for the following lot numbers and expiration dates: Lot 17KU03006 or 17KU03007 for 3-liter bags (NDC 49230-209-30), and Lot 17KU03004 or 17KU03005 for 2-liter bags (NDC 49230-209-23). All affected lots have an expiration date of August 2019.
  2. Immediately stop using any dialysis solution from the affected lot numbers.
  3. Contact your healthcare provider or pharmacist to discuss your treatment options and to arrange for replacement medical supplies.
  4. Return any unused, affected product to your clinic or the place of purchase for a refund.
  5. Contact Fresenius Medical Care Renal Therapies Group, LLC for further instructions on returning the product and receiving replacements.
  6. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

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, 2.5% Low Mg/Low Ca Single Bag (3L 4-pack)
Model:
NDC 49230-209-30
D-0604-2018
Lot Numbers:
17KU03006 (Exp. 08/2019)
17KU03007 (Exp. 08/2019)
Date Ranges: Exp. 08/2019
Product: DELFLEX Peritoneal Dialysis Solution, 2.5% Low Mg/Low Ca Single Bag (2L 6-pack)
Model:
NDC 49230-209-23
D-0604-2018
Lot Numbers:
17KU03004 (Exp. 08/2019)
17KU03005 (Exp. 08/2019)
Date Ranges: Exp. 08/2019

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 79403
Status: Resolved
Manufacturer: Fresenius Medical Care Renal Therapies Group, LLC
Sold By: clinics; direct to patients
Manufactured In: United States
Units Affected: 3,734 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.