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. To date, there have been no customer complaints received and there have been no reports of serious injury or death associated with this issue.
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.
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. Product was distributed Nationwide within the United States to domestic distributors.
B. Braun has notified its distributors and customers by an official recall notice sent via certified registered mail and has arranged for return of all recalled products.
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