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B. Braun is recalling five lots because of fluid leakage, which could expose patients to a bacterial or fungal infection.
B. Braun Medical is voluntarily recalling five lots of 0.9% sodium chloride for injection 250 ml in excel that was distributed nationwide.
The voluntary recall has been initiated due to fluid leakage or low fill volume of the respective containers, the company said in a news release posted on FDA’s website.
“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,” company executives said.
The pharma maker has not received any reports of adverse events related to the recall.
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,” the pharma maker said
The 0.9% sodium chloride for injection in excel is indicated for extracellular fluid replacement, treatment of metabolic alkalosis in the presence of fluid loss and mild sodium depletion. It is also used as a priming solution in hemodialysis procedures and may be used to initiate and terminate blood transfusions without hemolyzing red blood cells.
The five lots of 0.9% sodium chloride for injection (NDC 0264-780020) being recalled include: