BD Expands Urgent Recall of Alaris Pump Infusion Sets Amid Critical Infusion Delivery Risks
Becton Dickinson (BD) and its subsidiary CareFusion have escalated a Class I voluntary recall for the BD Alaris Pump Module model 8100, issuing a second „Urgent Medical Device Recall (Correction)“ letter that adds 15 more affected infusion sets, updated corrective actions, and enhanced risk warnings. The U.S. Food and Drug Administration (FDA) has flagged this as the most serious recall type, citing potential for serious injury or death due to inaccurate medication delivery. As of June 11, 2025, no serious injuries or deaths have been reported, but the issue poses heightened dangers to vulnerable patients like neonates and those in critical care. 0 1 6 This update builds on the initial recall launched July 8, 2025, and expanded July 17, 2025, following internal testing that revealed performance deviations in certain infusion sets. The FDA’s Early Alert, refreshed as of September…
