Becton Dickinson Files for Updated FDA Clearance for Infusion Pump

April 28, 2021

Becton Dickinson has submitted a 510(k) clearance application for its updated BD Alaris system, a widely-used infusion pump that has seen a string of recalls in the U.S.

The system delivers medications, fluids and blood products through a single platform that includes large volume pumps, syringe pumps and patient-controlled analgesia modules for adult, newborn and pediatric patients.

The company said its submission is meant to bring its regulatory clearance for the system up to date, implement updated features and address the issues it’s seen with recalls, including a new version of the device’s software that will provide clinical, operational and cybersecurity updates.

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