IV Bags Recalled Over Leakage Concerns

B. Braun Medical Inc is recalling nearly 80,000 bags containing 0.9% sodium chloride injection, according to the July 19, 2023, US Food and Drug Administration (FDA) Enforcement Report. The recall was issued because the bags have the potential to leak and compromise the drug’s sterility. 

The recall affects 0.9% sodium chloride injection, 1000 mL Excel Plus container (NDC 0264-5802-00), from lots 0061858305 and 0061858306 (Exp 3/31/25). The product was distributed throughout the United States.

B. Braun Medical voluntarily initiated the recall July 5, 2023. On July 13, 2023, the FDA designated the recall Class II. The classification signals that use of the affected product may cause temporary or medically reversible adverse health consequences, or a remote possibility of serious harm.

Sodium chloride injection is administered intravenously to supply water and salt to the body.