Fluid Replacement Bags Recalled

B Braun Medical Inc is recalling 33,742 bags of .9% sodium chloride injection due to a lack of sterility assurance. According to the March 23, 2022, US Food and Drug Administration (FDA) Enforcement Report, the bags may leak.

The recall affects .9% sodium chloride injection, 250 mL Excel IV Container (NDC 0264-7800-20), from lots J1E086, J1E204, and J1E213 (Exp. 5/31/23), and J1H137 and J1H138 (Exp. 6/30/23). The product was distributed throughout the United States.

B Braun Medical voluntarily initiated the recall February 25, 2022. On March 17, 2022, the FDA designated the recall Class II, communicating use of the product may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm.

According to B Braun Medical, .9% sodium chloride injection is indicated for extracellular fluid replacement, treatment of metabolic alkalosis in the presence of fluid loss, and mild sodium depletion.