Medications & Supplements/Prescription Drugs

Fresenius Medical Care Saline Solution Recalled for Sterility Concerns

Agency Publication Date: December 2, 2022

Summary

Fresenius Medical Care North America has recalled 4,097 cases of 0.9% Sodium Chloride Injection, USP (saline solution) sold in 1000mL bags. The recall was initiated because the packaging may leak, which prevents the product from remaining sterile. Using a non-sterile injectable medication can lead to serious infections or other health complications for patients. These saline bags were distributed nationwide in 12-pack cases.

Risk

The leakage in the IV bags compromises the assurance of sterility for the saline solution. If contaminated or non-sterile solution is administered to a patient, it poses a significant risk of infection.

What You Should Do

This recall affects 1000mL bags of 0.9% Sodium Chloride Injection, USP (NDC 49230-300-10) sold in 12-count cases under the Fresenius Medical Care North America brand.
Identify affected products by checking for lot numbers 22HU05062, 22HU06059, or 22HU05035 with an expiration date of 06/30/2023, or lot number 22JU05001 with an expiration date of 07/31/2023.
Stop using the recalled product immediately.
Contact Fresenius Medical Care Holdings, Inc. or your medical distributor to arrange for the return of any remaining bags from the affected lots.
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

Other Action

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: 0.9% Sodium Chloride Injection, USP (1000mL Bag)by Fresenius Medical Care North America

Variants: 12 PK, 1000mL

Lot Numbers:

22HU05062 (Exp 06/30/2023)

22HU06059 (Exp 06/30/2023)

22HU05035 (Exp 06/30/2023)

22JU05001 (Exp 07/31/2023)

NDC:

49230-300-10

Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 91226

Status: Active

Manufacturer: Fresenius Medical Care Holdings, Inc.

Sold By: Hospitals; Clinics; Medical Wholesalers

Manufactured In: United States

Units Affected: 4,097 cases/12 bags per case

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 · 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

What You Should Do

This recall affects 1000mL bags of 0.9% Sodium Chloride Injection, USP (NDC 49230-300-10) sold in 12-count cases under the Fresenius Medical Care North America brand.

Identify affected products by checking for lot numbers 22HU05062, 22HU06059, or 22HU05035 with an expiration date of 06/30/2023, or lot number 22JU05001 with an expiration date of 07/31/2023.

Stop using the recalled product immediately.

Contact Fresenius Medical Care Holdings, Inc. or your medical distributor to arrange for the return of any remaining bags from the affected lots.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

Affected Products

Product: 0.9% Sodium Chloride Injection, USP (1000mL Bag)by Fresenius Medical Care North America

Variants: 12 PK, 1000mL

Lot Numbers:

22HU05062 (Exp 06/30/2023)

22HU06059 (Exp 06/30/2023)

22HU05035 (Exp 06/30/2023)

22JU05001 (Exp 07/31/2023)

NDC:

49230-300-10

Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs.