The recall was issued because of fluid leakage or low fill volume of the product’s 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,” the company’s recall announcement said. “There is a remote possibility this could lead to bloodstream infection. B. Braun has not received any reports of adverse events related to this recall.”
The medical device manufacturer is in the process of notifying its distributors and customers of the recall notice and is arranging for return of recalled products.
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