The voluntary recall involves certain infusion sets used with the BD Alaris Pump Module model 8100 due to performance deviations that could impact dose accuracy.
BD has expanded a Class I voluntary recall for a subset of infusion sets compatible with its Alaris Pump Module model 8100. The US Food and Drug Administration (FDA) has designated the action as Class I, its most serious type, indicating a potential for patient death or serious adverse events.
The recall, initially started in July 2025, was expanded to include 15 additional, previously discontinued pump infusion sets that may still be in hospital inventory. According to the company, the action was initiated after internal testing revealed that certain infusion sets could cause the pump to perform outside the specifications described in its user manual, potentially affecting infusion delivery and dose accuracy.
The company states that these performance deviations are attributable to the infusion sets’ design features, such as filters and other in-line components. While no customer complaints associated with this issue have been reported to date, the potential risk is higher for vulnerable patient populations, including neonatal and critically ill patients.
The severity of potential outcomes depends on the medication being administered and the patient’s condition, according to the announcement. The affected products were distributed in the US, including Guam and Puerto Rico, as well as in Canada, Belgium, and South Africa.
BD has issued an update to customers detailing corrective actions, risk mitigations, and recommendations for alternate Alaris Pump infusion sets. The update also includes a list of the 15 newly added infusion sets. Customers can find more information on the company’s website or report complaints to the BD Complaint Center at 1-844-823-5433.
ID 10617611 © Risto Viitanen | Dreamstime.com
