Medications & Supplements/Prescription Drugs

Fresenius Saline Solution Bags Recalled for Leakage and Sterility Issues

Agency Publication Date: October 20, 2022

Summary

Fresenius Medical Care North America has recalled 16,006 cases of its 0.9% Sodium Chloride Injection, USP (saline solution) because the bags may leak. This leakage creates a significant risk that the saline is no longer sterile and could be contaminated. The saline was distributed nationwide to healthcare facilities in 1000mL bags, with 12 bags per case. No injuries or illnesses have been reported to date regarding this issue.

Risk

Leakage in IV bags compromises the sterile barrier of the medication. Using a non-sterile saline solution for injection can lead to serious systemic infections or other life-threatening health complications in patients.

What You Should Do

This recall affects 1000mL bags of Fresenius Medical Care North America 0.9% Sodium Chloride Injection, USP (saline solution) sold in 12-count cases (NDC 49230-300-10).
Identify if your product is affected by checking for these lot numbers and expiration dates: 22EU05043 (Exp 5/21/2023), 22HU05018 (Exp 6/9/2023), 22HU05019 (Exp 6/10/2023), 22HU05025 (Exp 6/12/2023), 22HU05026 (Exp 6/12/2023), 22HU05049 (Exp 6/22/2023), 22HU05053 (Exp 6/24/2023), 22HU05054 (Exp 6/25/2023), 22HU05055 (Exp 6/25/2023), 22HU06027 (Exp 6/11/2023), 22HU06049 (Exp 6/23/2023), 22HU06055 (Exp 6/24/2023), 22HU06056 (Exp 6/25/2023), 22JU05008 (Exp 7/4/2023), 22KU06036 (Exp 8/19/2023), and 22JU06023 (Exp 7/8/2023).
Stop using the recalled product immediately.
Contact Fresenius Medical Care Holdings, Inc. or your authorized distributor to arrange for the return of any remaining inventory.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have further questions.

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

Lot Numbers:

22EU05043 (Exp 5/21/2023)

22HU05018 (Exp 6/9/2023)

22HU05019 (Exp 6/10/2023)

22HU05025 (Exp 6/12/2023)

22HU05026 (Exp 6/12/2023)

22HU05049 (Exp 6/22/2023)

22HU05053 (Exp 6/24/2023)

22HU05054 (Exp 6/25/2023)

22HU05055 (Exp 6/25/2023)

22HU06027 (Exp 6/11/2023)

22HU06049 (Exp 6/23/2023)

22HU06055 (Exp 6/24/2023)

22HU06056 (Exp 6/25/2023)

22JU05008 (Exp 7/4/2023)

22KU06036 (Exp 8/19/2023)

22JU06023 (Exp 7/8/2023)

NDC:

49230-300-10

16,006 cases of twelve bags each affected.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90997

Status: Active

Manufacturer: Fresenius Medical Care Holdings, Inc.

Sold By: Fresenius Medical Care North America; Prescription Only (Rx Only)

Manufactured In: United States

Units Affected: 16,006 cases of twelve bags each

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 Fresenius Medical Care North America 0.9% Sodium Chloride Injection, USP (saline solution) sold in 12-count cases (NDC 49230-300-10).

Identify if your product is affected by checking for these lot numbers and expiration dates: 22EU05043 (Exp 5/21/2023), 22HU05018 (Exp 6/9/2023), 22HU05019 (Exp 6/10/2023), 22HU05025 (Exp 6/12/2023), 22HU05026 (Exp 6/12/2023), 22HU05049 (Exp 6/22/2023), 22HU05053 (Exp 6/24/2023), 22HU05054 (Exp 6/25/2023), 22HU05055 (Exp 6/25/2023), 22HU06027 (Exp 6/11/2023), 22HU06049 (Exp 6/23/2023), 22HU06055 (Exp 6/24/2023), 22HU06056 (Exp 6/25/2023), 22JU05008 (Exp 7/4/2023), 22KU06036 (Exp 8/19/2023), and 22JU06023 (Exp 7/8/2023).

Stop using the recalled product immediately.

Contact Fresenius Medical Care Holdings, Inc. or your authorized distributor to arrange for the return of any remaining inventory.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have further questions.

Affected Products

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

Variants: 12 PK, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs

Lot Numbers:

22EU05043 (Exp 5/21/2023)

22HU05018 (Exp 6/9/2023)

22HU05019 (Exp 6/10/2023)

22HU05025 (Exp 6/12/2023)

22HU05026 (Exp 6/12/2023)

22HU05049 (Exp 6/22/2023)

22HU05053 (Exp 6/24/2023)

22HU05054 (Exp 6/25/2023)

22HU05055 (Exp 6/25/2023)

22HU06027 (Exp 6/11/2023)

22HU06049 (Exp 6/23/2023)

22HU06055 (Exp 6/24/2023)

22HU06056 (Exp 6/25/2023)

22JU05008 (Exp 7/4/2023)

22KU06036 (Exp 8/19/2023)

22JU06023 (Exp 7/8/2023)

NDC:

49230-300-10

16,006 cases of twelve bags each affected.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90997

Status: Active

Manufacturer: Fresenius Medical Care Holdings, Inc.

Sold By: Fresenius Medical Care North America; Prescription Only (Rx Only)

Manufactured In: United States

Units Affected: 16,006 cases of twelve bags each

Distributed To: Nationwide