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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

B. Braun Potassium Chloride Injection Recalled for Sterility Risk

Agency Publication Date: March 8, 2024
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Summary

B. Braun Medical Inc. is recalling 22,752 bags of Potassium Chloride for Injection Concentrate USP (potassium chloride). The recall involves 250 mL EXCEL bags which may have tiny pinholes within the blue label characters, resulting in leaks. Hospitals and healthcare facilities should stop using the affected bags immediately and contact B. Braun Medical Inc. or their distributor to arrange for the return of the product.

Risk

Pinholes in the IV bag compromise the sterile barrier, potentially allowing bacteria or other contaminants to enter the medication. If a patient is injected with contaminated fluid, it could lead to serious, life-threatening infections.

What You Should Do

  1. This recall affects Potassium Chloride for Injection Concentrate USP (500 mEq/250 mL) in 250 mL EXCEL bags sold under the B. Braun Medical Inc. brand (NDC 0264-1944-20).
  2. Check your clinical inventory for lot numbers J2S007 (expiration date 12/31/2024) and J3A115 (expiration date 01/31/2025).
  3. Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.
  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: Potassium Chloride for Injection Concentrate USP, 500 mEq/250 mL (2 mEq/mL), 250 mL Bag
Variants: 500 mEq/250 mL (2 mEq/mL), 250 mL Bag
Lot Numbers:
J2S007 (Exp: 12/31/2024)
J3A115 (Exp: 01/31/2025)
NDC:
0264-1944-20

Pinholes found within the blue label characters on the EXCEL bag, specifically within the dotted characters on the label.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94184
Status: Resolved
Manufacturer: B. Braun Medical Inc
Sold By: Hospitals; Infusion Centers; Wholesalers
Manufactured In: United States
Units Affected: 22,752 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.