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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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High RiskFDA Drug
Medications & Supplements/Prescription Drugs

B. Braun Sodium Chloride Injection Recalled for Leaking Bags and Sterility Risk

Agency Publication Date: March 17, 2022
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Summary

B. Braun Medical, Inc. is recalling 33,742 bags of 0.9% Sodium Chloride Injection USP (saline) in 250 mL Excel Containers. The recall was initiated because some bags were found to be leaking, which compromises the sterility of the solution. No injuries or incidents have been reported to date, but using a non-sterile injectable product can lead to serious infections. Facilities should contact their supplier or B. Braun to return any remaining inventory from the affected lots.

Risk

The leaking bags create a pathway for bacteria or other environmental contaminants to enter the saline solution, destroying its sterility. Injecting a non-sterile fluid directly into a patient's bloodstream poses a significant risk of severe, life-threatening infections.

What You Should Do

  1. This recall affects 0.9% Sodium Chloride Injection USP (250 mL Excel Container, NDC 0264-7800-20) with lot numbers J1E086, J1E204, J1E213 (Exp 5/31/2023) and J1H137, J1H138 (Exp 6/30/2023).
  2. Stop using the recalled product immediately.
  3. Contact B. Braun Medical, Inc. or your distributor to arrange for the return of any unused 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: 0.9% Sodium Chloride Injection USP, 250 mL Excel Containerby B. Braun Medical Inc.
Variants: Rx only
Lot Numbers:
J1E086 (Exp 5/31/2023)
J1E204 (Exp 5/31/2023)
J1E213 (Exp 5/31/2023)
J1H137 (Exp 6/30/2023)
J1H138 (Exp 6/30/2023)
NDC:
0264-7800-20

Recall #: D-0655-2022; Distributed to hospitals and healthcare providers.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 89665
Status: Resolved
Manufacturer: B. Braun Medical, Inc.
Sold By: Hospitals; Healthcare facilities; Wholesalers
Manufactured In: United States
Units Affected: 33,742 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.