Class I Recall for Intravenous Solution

B. Braun Medical Inc. is recalling 63 444 containers of 0.9% sodium chloride injection for the potential presence of particulate matter and fluid leakage. 

The recall has been designated Class I, according to the August 28, 2024, US Food and Drug Administration (FDA) Enforcement Report. Per the classification, use of the recalled product could cause serious adverse health consequences or death.

“There is a reasonable probability of embolic phenomena such as stroke or ischemia/infarct to other organs and possible infection if these particulates are not sterile that could lead to permanent damage or impairment of body function, which could be life-threatening,” B. Braun Medical stated in an August 8, 2024, company announcement.

The recall affects 0.9% sodium chloride injection, E8000, in 1000-mL containers (NDC 0264-7800-09) from lots J2L763 and J2L764 (Exp. 3/31/25). The containers were distributed in the United States in February 2024.

“The affected batches were inadvertently released to the market prior to the completion of the required acceptance activities for embedded particulate matter, which may result in leakage,” the company stated. “To date, there have been no customer complaints received, and there have been no reports of serious injury or death associated with this issue.”

B. Braun Medical voluntarily initiated the recall on July 24, 2024. The FDA issued its Class I designation on August 19, 2024.

The intravenous solution is indicated as a source of electrolytes and water for hydration as well as for extracellular fluid replacement and treatment of metabolic alkalosis in the presence of fluid loss and mild sodium depletion. It is also indicated as a priming solution in hemodialysis procedures and as a pharmaceutic aid and diluent for the infusion of compatible drug additives.