August 01, 2019
Baxter Healthcare Corporation is recalling 139,680 containers of 0.9% sodium chloride injection due to a lack of sterility assurance. According to the July 31, 2019, US Food and Drug Administration (FDA) Enforcement Report, the containers have the potential to leak.
The recall affects 100-mL Viaflex containers of 0.9% sodium chloride injection (NDC 0338-0049-38) from lots P389684 and P389742, which have an expiration date of August 31, 2020. The containers were distributed in the United States and Puerto Rico.
Baxter Healthcare Corporation voluntarily initiated the recall July 18, 2019. On July 23, 2019, the FDA designated the recall Class II. Under Class II recalls, use of the product could cause temporary or medically reversible adverse health consequences, or a remote possibility of serious harm.
Sodium chloride injection is administered intravenously for fluid and electrolyte replenishment.