B. Braun Medical—a maker of IV solutions for hospitals, among other products—has initiated a recall in the United States and Canada spurred by particulate contamination.
The product pull, which revolves around a single lot of Excel lactated ringers injection shipped to hospitals and healthcare facilities, echoes a sodium chloride recall B. Braun launched in August of 2024.
The company is moving to take the Excel batch off hospital shelves due to the potential presence of particulate matter in the solution, specifically identified as cellulose cotton fiber. Individual particles have also been ID’d as cellulose wood fiber and polystyrene, B. Braun said in a recall notice posted to the FDA’s website this week.
Injecting a solution containing particles of foreign material carries a “reasonable probability” of blocking pulmonary blood vessels, occluding other blood vessels—which can lead to tissue death and possible organ damage—or causing inflammation of the walls of veins, which can cause clotting, the company cautioned.
As of Aug. 19, B. Braun had not received any adverse event reports tied to the suspect Excel batch.
The product provides a source of water and electrolytes for patients in need of hydration and fluid replacement. It is used in adults, children and newborns alike. The specific batch being pulled was distributed across the U.S. and to Canada from late August through the end of September 2024. The lot was set to expire on Nov. 30 of this year.
In recent years, B. Braun has garnered headlines for its role helping fill gaps in U.S. IV fluid supply after Hurricanes Helene and Milton devastated the southeastern U.S. in late 2024 and forced the temporary closure of fellow IV specialist Baxter’s chief manufacturing facility in Marion, North Carolina.
Several months before B. Braun pitched in for Baxter, however, the company recalled two lots of injectable 0.9% sodium chloride in the U.S. in April of 2024, similarly attributing the move to the potential for particulate matter presence, as well as fluid leakage from the containers the solution was stored in.
Like the Excel product being recalled now, the sodium chloride solution was used in both kids and adults as a source of electrolytes and water for hydration, with specific approvals for extracellular fluid replacement, treatment of metabolic alkalosis with fluid loss and mild sodium depletion.
At the time, B. Braun said it mistakenly released the affected batches to domestic distributors across the U.S. before completing required acceptance activities for embedded particulate matter.