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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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Critical RiskFDA Drug
Medications & Supplements/Prescription Drugs

B. Braun 0.9% Sodium Chloride Injection USP Recalled for Particulate Matter

Agency Publication Date: August 19, 2024
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Summary

B. Braun Medical Inc. is recalling 63,444 containers of 0.9% Sodium Chloride Injection USP (Normal Saline) due to the presence of particulate matter (unintended particles) in the solution. This recall affects 1000 mL containers labeled with Catalog Number E8000 and NDC 0264-7800-09. Because this is a clinical injectable medication administered by healthcare professionals, hospitals and clinics must stop use immediately and return affected units to the manufacturer.

Risk

Injecting a solution that contains particulate matter can cause serious health complications, such as blood vessel blockages (embolism), inflammation, or damage to vital organs like the lungs or kidneys.

What You Should Do

  1. This recall involves 1000 mL containers of B. Braun 0.9% Sodium Chloride Injection USP (Normal Saline), which is a prescription medication used for intravenous infusion.
  2. Identify affected product by looking for Catalog Number E8000 and NDC 0264-7800-09 on the label. The affected lot numbers are J2L763 and J2L764 with an expiration date of March 31, 2025.
  3. Stop using the recalled product immediately. Contact B. Braun Medical Inc. or your distributor to arrange for the return of any affected units.
  4. 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 (1000 mL)
Variants: Rx only
Model:
E8000
Lot Numbers:
J2L763 (Exp 31 March 2025)
J2L764 (Exp 31 March 2025)
NDC:
0264-7800-09

Distributed nationwide within the U.S.A.

Product Images

“Label, 0.9% Sodium Chloride for Injection USP 1000 mL in E3 containers”

“Label, 0.9% Sodium Chloride for Injection USP 1000 mL in E3 containers”

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95035
Status: Active
Manufacturer: B. Braun Medical Inc
Sold By: Hospitals; Infusion Centers; Healthcare Distributors
Manufactured In: United States
Units Affected: 63,444 containers
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 · FDA Press Release · 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.