TOPIC: 0.9% Sodium Chloride for Injection USP, 1000 mL in E3 Containers by B. Braun: Recall - Due to the Potential for Particulate Matter and Leakage
AUDIENCE: Patient, Health Professional, Pharmacy
ISSUE: B. Braun Medical is recalling two (2) lots of 0.9% Sodium Chloride for Injection USP, 1000 mL in E3 containers within the United States due to the potential for particulate matter and fluid leakage of the respective containers.
The affected batches were inadvertently released to the market prior to the completion of the required acceptance activities for embedded particulate matter which may result in leakage.
Risk Statement: There is a reasonable probability of embolic phenomena such as stroke or ischemia/infarct to other organs and possible infection if these particulates are not sterile that could lead to permanent damage or impairment of body function which could be life-threatening.
To date, there have been no customer complaints received and there have been no reports of serious injury or death associated with this issue.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND: This intravenous solution is indicated for use in adults and pediatric patients as a source of electrolytes and water for hydration. 0.9% Sodium Chloride for Injection USP in E3 is indicated for extracellular fluid replacement, treatment of metabolic alkalosis in the presence of fluid loss and mild sodium depletion. 0.9% Sodium Chloride Injection USP is also indicated for use as a priming solution in hemodialysis procedures and may be used to initiate and terminate blood transfusions without hemolyzing red blood cells. Sodium Chloride Injection USP is also indicated as a pharmaceutic aid and diluent for the infusion of compatible drug additives.
RECOMMENDATIONS:
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Facilities and distributors that have product which is being recalled should discontinue use immediately and contact the B. Braun Medical Inc. Customer Support Department at 800-227-2862.
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Adverse reactions or quality problems experienced with this product, or questions about this recall may be reported to B. Braun’s Postmarket Surveillance Department by calling 1-833-425-1464.
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