BD Alaris Pump Module recalled due to Pump Performance not as per Manual, USA

United States

BD (Becton, Dickinson and Company) a leading global medical technology company, today expanded their Class I voluntary recall initiated in the United States on July 8, 2025 and expanded on July 17, 2025 to inform customers of worst-case performance, under certain use cases, for the BD Alaris™ Pump Module model 8100 when used with a subset of compatible pump infusion sets, as compared to the performance described in the user manual. The update includes an expansion of 15 additional impacted pump infusion sets included in the recall, as well as new corrective actions and risk information. The 15 additional sets had been previously discontinued but may remain in inventory based on the expiration date. The products included in the recall were distributed nationwide in the United States, including Guam and Puerto Rico, and in Canada, Belgium and South Africa.

Pump performance variations as compared to the performance described in the user manual could impact infusion delivery in the following ways:
- Flow rate and loading bolus dose accuracy (over/under infusion),
- Upstream and downstream occlusion alarm delay,
- and post-occlusion bolus volume (POBV) over infusion,

which could adversely impact infusion performance and dose accuracy. The severity and nature of these outcomes depend on the type of medication, fluid, or infusate being administered, as well as the individual patient’s condition.

The deviations in performance from the previously published ranges are attributable to these pump infusion sets' design features, such as filters and other in-line components.

This issue was identified through internal testing and, to date, BD has not received any complaints associated with this issue. The affected products have the potential to result in patient death or serious adverse events, with a particular higher risk to vulnerable patient populations such as neonates and critically ill patients. The recall has been designated as a Class I recall by the U.S. Food and Drug Administration (FDA).

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bd-provides-update-voluntary-recall-certain-bd-alaristm-pump-infusion-sets