IV Bags Recalled Over Sterility Concerns

B. Braun Medical Inc is recalling more than 1 million bags containing 0.9% sodium chloride injection. According to the March 1, 2023, US Food and Drug Administration (FDA) Enforcement Report, the recall was prompted by a lack of sterility assurance due to leaking bags.

The recall affects the following products, which were distributed throughout the United States:

• 0.9% sodium chloride injection, 500-mL Excel Plus container (NDC 0264-5802-10), from lots 0061794230 and 0061794232 (Exp. 1/31/24); 0061797779, 0061797780, 0061797781, and 0061797783 (Exp. 2/29/24); 0061797784, 0061797785, 0061797786, 0061797787, and 0061797788 (Exp. 3/31/24); and 0061809680 (Exp. 4/30/24); and 
• 0.9% sodium chloride injection, 1000-mL Excel Plus container (NDC 0264-5802-00), from lots 0061786962 (Exp. 11/30/23); 0061797767 (Exp. 4/30/24); 0061797768, 0061787769, 0061797770, 0061797771, 0061797772, 0061797773, 0061797774, 0061797775, 0061797776, 0061812946, 0061812947, 0061812948, 0061812949, and 0061812950 (Exp. 5/31/24); 0061816017, 0061816018, 0061816019, 0061816020, 0061816021, 0061816358, and 0061816359 (Exp. 6/30/24); 0061816361, 0061816362, 0061816363, 0061816364, 0061818516, 0061818517, and 0061818518 (Exp. 7/31/24); and 0061821562, 0061821563, 0061821564, 0061823709, 0061823710, 0061823711, 0061823714, 0061823715, 0061823716, 0061824770, 0061824771, 0061824772, 0061824773, 0061824774, 0061824775, 0061824776, 0061824777, 0061826486, 0061826487, and 0061826488 (Exp. 8/31/24).

B. Braun Medical voluntarily initiated the recall February 10, 2023. On February 23, 2023, the FDA designated the recall Class II. The classification communicates 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.