March 4, 2022 – B. Braun Medical Inc. (Bethlehem, PA) announced it is voluntarily recalling five lots of 0.9% Sodium Chloride for Injection USP 250ML in Excel within the United States to the hospital/user level.
The voluntary recall was initiated due to fluid leakage or low fill volume of the respective containers.
The biggest risk with a slow leak in any intravenous solution preparation is a break in sterility which poses a risk for the patient being exposed to a bacterial or fungal infection. There is a remote probability this could lead to bloodstream infection, the company says.
B. Braun has not received any reports of adverse events related to this recall.
0.9% Sodium Chloride for Injection USP in Excel 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 in Excel 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.
Product was distributed Nationwide within the United States to domestic distributors.
B. Braun is notifying its distributors and customers by an official recall notice sent via certified registered mail and is arranging for return of all recalled products. Facilities and distributors that have product which is being recalled should discontinue use immediately and contact the B. Braun Medical Inc. Customer Support Department to arrange for product return.