Last Updated on September 30, 2024 by The Health Master
Drug recall
B. Braun Medical Inc. has issued a voluntary drug recall for specific batches of its 0.9% Sodium Chloride for Injection USP 1000 mL (Saline Solution) in E3 containers.
The recall stems from concerns about potential particulate matter and fluid leakage within the containers.
Why Was this Drug Recall?
The affected saline solution batches were prematurely released to the market before undergoing essential quality checks for particulate contamination.
This oversight could lead to leakage, posing a serious health risk to patients.
Potential Risks
It’s crucial to understand the potential dangers associated with this drug recall.
If the saline solution contains particulate matter, it could lead to severe complications, including:
- Embolic phenomena: This refers to the blockage of blood vessels by foreign particles, which can result in stroke or ischemia (reduced blood flow).
- Infection: If the particles are not sterile, they can introduce harmful bacteria into the bloodstream, leading to infections.
These complications can cause permanent damage, impair bodily functions, and, in the worst cases, be life-threatening.
Affected Product Details
To help you identify if you have an affected product, here’s a breakdown of the recalled items:
| Product Catalog Number | NDC Number | Product Description | Lot Number | Expiration Date |
|---|---|---|---|---|
| E80000264-7800-09NACL INJ 0.9% | 1000ML – E8000J2L763, J2L76401 | 0.9% Sodium Chloride for Injection USP in E3 | Feb. 2024 – 28.Feb.2024 | 31.Mar.2025 |
Note: The product was distributed nationwide within the United States.
What to Do If You Have a Recalled Drug
If you or your healthcare provider have any of the recalled saline solution, please discontinue use immediately.
Contact the B. Braun Medical Inc. Customer Support Department at 800-227-2862 to arrange for product return.
Conclusion
B. Braun is taking this drug recall seriously and is working closely with the USFDA to ensure the safety of patients.
It’s essential for healthcare providers and patients to be aware of this drug recall and take appropriate action to protect public health.
Disclaimer: This article is intended for informational purposes only and does not constitute medical advice. Always consult with a healthcare
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
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