Medications & Supplements/Prescription Drugs

Fresenius Medical Care Holdings, Inc.: Sodium Chloride 0.9% Injection Recalled Due to Sterilization Deviation

Agency Publication Date: March 19, 2020

Summary

Fresenius Medical Care North America has recalled approximately 32,592 bags of Sodium Chloride 0.9% Injection, USP (1000 mL). This prescription medication, commonly used for intravenous fluid replacement, was recalled because chemical indicators were not positioned correctly during the sterilization process, which may mean the product was not properly sterilized. These affected lots were distributed throughout the United States with expiration dates in April and May 2020.

Risk

Improper positioning of sterilization indicators means there is no confirmation that these specific bags reached the required temperature or conditions to ensure they are sterile. Using a non-sterile injectable drug can lead to serious systemic infections or life-threatening complications for patients.

What You Should Do

Check your medical supplies for Sodium Chloride 0.9% Injection, USP, in 1000 mL bags manufactured by Fresenius Medical Care North America.
Verify the lot numbers on the packaging: look for lot numbers 19EG02012 or 19EG02019 (both with Expiration Date 05/2020) and lot number 19DG02050 (with Expiration Date 04/2020).
Immediately stop using any product from these specific lot numbers and set them aside to ensure they are not administered to patients.
Contact your healthcare provider or pharmacist for guidance regarding alternative supplies and to report any concerns.
Return any unused product from the affected lots to the pharmacy or place of purchase for a refund and contact Fresenius Medical Care at 1-888-723-3332 for further instructions on returning the product.
For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full 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: Sodium Chloride 0.9% Injection, USP (1000 mL)

Model:

D-1064-2020

Lot Numbers:

19EG02012 (Exp. Date 05/2020)

19EG02019 (Exp. Date 05/2020)

19DG02050 (Exp. Date 04/2020)

Date Ranges: Expiration Date 05/2020, Expiration Date 04/2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 85228

Status: Resolved

Manufacturer: Fresenius Medical Care Holdings, Inc.

Sold By: Hospitals; Clinics; Healthcare providers

Manufactured In: United States

Units Affected: 32,592 bags

Distributed To: Nationwide

Agency Last Updated: March 26, 2020

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 · 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.

Summary

Risk

What You Should Do

Check your medical supplies for Sodium Chloride 0.9% Injection, USP, in 1000 mL bags manufactured by Fresenius Medical Care North America.

Verify the lot numbers on the packaging: look for lot numbers 19EG02012 or 19EG02019 (both with Expiration Date 05/2020) and lot number 19DG02050 (with Expiration Date 04/2020).

Immediately stop using any product from these specific lot numbers and set them aside to ensure they are not administered to patients.

Contact your healthcare provider or pharmacist for guidance regarding alternative supplies and to report any concerns.

Return any unused product from the affected lots to the pharmacy or place of purchase for a refund and contact Fresenius Medical Care at 1-888-723-3332 for further instructions on returning the product.

For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.