WASHINGTON, D.C. — The Food and Drug Administration announced that B. Braun Medical Inc. is recalling two lots of 0.9% Sodium Chloride for Injection USP 1000 mL E3 containers. This voluntary recall affects products distributed in the United States and is due to potential particulate matter and fluid leakage.
The affected batches were inadvertently released before completing necessary acceptance activities. No customer complaints or reports of serious injury have been received to date.
Risk and Product Details
The recall involves:
- Catalog Number: E8000
- NDC Number: 0264-7800-09
- Lot Numbers: J2L763, J2L764
- Expiration Date: 31-Mar-2025
- Distribution Range: 01-Feb-2024 – 28.Feb.2024
These intravenous solutions are used for hydration and electrolyte replacement in adults and pediatric patients. They are also indicated for treating metabolic alkalosis, mild sodium depletion, and as a priming solution in hemodialysis.
Health Risks
There is a reasonable probability that particulate matter could lead to embolic phenomena such as stroke or organ ischemia. If the particulates are not sterile, there is a risk of infection that could cause permanent damage or be life-threatening.
Actions Taken
B. Braun has notified distributors and customers via certified mail. They have arranged for the return of all recalled products. Facilities and distributors should discontinue use immediately and contact B. Braun’s Customer Support Department at 800-227-2862 for product return arrangements.
Reporting Adverse Reactions
Adverse reactions or quality problems can be reported to B. Braun’s Postmarket Surveillance Department at 1-833-425-1464. They can also be reported to the FDA’s MedWatch Adverse Event Reporting program online, by mail, or by fax.
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