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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

Lactated Ringer's Injection Recalled for Potential Sterility Loss and Leaking

Agency Publication Date: April 3, 2024
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Summary

B. Braun Medical Inc. is recalling 7,800 bags of Lactated Ringer's Injection USP (1,000mL) due to a potential defect that causes the EXCEL containers to leak. The recall affects product units with NDC 0264-7750-00 and lot J3N023. These leaks compromise the sterility of the intravenous fluid, which is required for patient safety during administration. The company initiated this voluntary recall after discovering the lack of sterility assurance.

Risk

If the injection bag leaks, the fluid inside is no longer guaranteed to be sterile. Administering a non-sterile injection to a patient can result in serious bloodstream infections or other life-threatening medical complications.

What You Should Do

  1. The recalled product is Lactated Ringer's Injection USP (1,000mL) sold in EXCEL containers with NDC 0264-7750-00, lot number J3N023, and an expiration date of March 31, 2026.
  2. Stop using the recalled product immediately.
  3. Contact B. Braun Medical Inc. or your medical distributor to arrange for the return of any affected bags.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Lactated Ringer's Injection USP (1000mL)
Variants: EXCEL CONTAINER, Rx only
Lot Numbers:
J3N023 (Exp 31 March 2026)
NDC:
0264-7750-00

Quantity affected: 7,800 bags

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94272
Status: Resolved
Manufacturer: B. Braun Medical Inc
Sold By: Hospitals; Healthcare Facilities; Medical Distributors
Manufactured In: United States
Units Affected: 7,800 bags
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.