B. Braun Medical has initiated a recall of a single lot of Excel lactated ringers injection across the United States and Canada due to particulate contamination concerns.
The recall affects product shipped to hospitals and healthcare facilities, with contamination identified as cellulose cotton fiber, cellulose wood fiber, and polystyrene particles found within the solution.
B. Braun issued the recall notice via the FDA’s website, warning that injecting a solution containing foreign material carries serious health risks for patients.
The company cautioned that there is a “reasonable probability” of the particles blocking pulmonary blood vessels, which can lead to tissue death and possible organ damage.
The contaminated solution can also cause inflammation of the walls of veins, potentially resulting in dangerous clotting events, according to B. Braun’s recall notice.
The Excel product serves as a source of water and electrolytes for patients requiring hydration and fluid replacement, and is used in adults, children, and newborns alike.
The affected batch was distributed across the US and into Canada from late August through the end of September 2024, with the lot set to expire on November 30 of this year.
As of August 19, B. Braun had not received any adverse event reports tied to the suspect Excel batch, offering some reassurance to affected healthcare facilities.
This recall echoes a sodium chloride product pull B. Braun launched in August 2024, when the company recalled two lots of injectable 0.9% sodium chloride similarly attributed to potential particulate matter presence.
That earlier recall also flagged fluid leakage from the containers the solution was stored in, with B. Braun acknowledging it had mistakenly released the affected batches before completing required acceptance activities for embedded particulate matter.
The sodium chloride solution, like the current Excel product, was used in both children and adults as a source of electrolytes and water, with approvals for extracellular fluid replacement and treatment of metabolic alkalosis with fluid loss.
B. Braun has also been widely recognised for its role in helping fill gaps in US IV fluid supply after Hurricanes Helene and Milton devastated the southeastern US in late 2024.
Those storms forced the temporary closure of fellow IV specialist Baxter’s chief manufacturing facility in Marion, North Carolina, prompting B. Braun to step in and help address the resulting supply shortfall.
The latest recall underscores ongoing quality control challenges across the IV solutions sector, even as manufacturers continue to face heightened scrutiny from regulators and healthcare providers.