FDA Classifies BD Infusion Pump Software Recall as Class I

The FDA has classified the recall of software used in Becton, Dickinson and Company’s (BD) infusion pumps as Class I, its most serious recall designation. While no injuries or deaths have been reported, continued use without corrective actions could cause serious harm or death.

Recalled Products:

• BD Alaris Systems Manager
• BD Care Coordination Engine Infusion Adapter

These software components help connect BD Alaris infusion pumps to hospital computers and electronic medical records. A software issue is causing delayed system responses, leading to outdated automated programming requests (APRs). This may result in over- or under-infusion of fluids, posing a severe patient safety risk.

BD and its CareFusion subsidiary have issued corrective action recommendations, including reviewing therapy parameters and notifying BD of affected products. The global infusion pump market, valued at $2.6 billion in 2023, is expected to reach $3.3 billion by 2033.

23-03-2025

• Pharma GMP
• Food GMP
• Clinical Research
• Medical Device
• Environmental Health and Safety
• Healthcare
• Nutrition