Leaky IV Bags Recalled

A lack of assurance of sterility has prompted Fresenius Medical Care Holdings Inc to recall 16,006 cases of 0.9% sodium chloride injection. The October 26, 2022, US Food and Drug Administration (FDA) Enforcement Report cited product leakage.

The recall affects 0.9% sodium chloride injection in 1000-mL bags, 12 bags per carton (NDC 49230-300-10), from lots 22EU05043 (Exp. 5/21/23), 22HU05018 (Exp. 6/9/23), 22HU05019 (Exp. 6/10/23), 22HU05025 and 22HU05026 (Exp. 6/12/23), 22HU05049 (Exp. 6/22/23), 22HU05053 (Exp. 6/24/23), 22HU05054 and 22HU05055 (Exp. 6/25/23), 22HU06027 (Exp. 6/11/23), 22HU06049 (Exp. 6/23/23), 22HU06055 (Exp. 6/24/23), 22HU06056 (Exp. 6/25/23), 22JU05008 (Exp. 7/4/23), 22KU06036 (Exp. 8/19/23), and 22JU06023 (Exp. 7/8/23). The product was distributed throughout the United States.

Fresenius Medical Care Holdings voluntarily initiated the recall October 11, 2022. The FDA designated the recall Class II on October 20, 2022. 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.