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Becton, Dickinson and Company’s BDX, or popularly known as BD, initiated the recall of its infusion pumps last month after customer reports indicated software issues, potentially leading to inaccurate therapy administration. The FDA designated BD’s recall of its infusion pump software as Class I, the most severe classification, last week. While no injuries or fatalities have been reported, the FDA warns that continued use of the affected software could result in serious harm or even death if appropriate corrective measures are not implemented.
The affected products include BD Alaris Systems Manager and BD Care Coordination Engine (CCE) Infusion Adapter.
Likely Trend of BDX Stock Following the News
Shares of BDX have lost 0.9% since the Class I classification of the recall last week. The company’s shares have gained 0.5% compared with the industry’s 1.7% growth so far this year. The S&P 500 Index declined 2.7% in the same period.
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BD has added the Alaris pump to its portfolio with the acquisition of CareFusion 303 in 2015. It has been selling the Alaris pump under a consent decree till 2023, except for intravenous administration sets and accessories. The consent decree authorized the FDA, in the event of any violations in the future, to order BD’s U.S. infusion pump business to cease manufacturing and distributing products, recall products or take other actions, and order the payment of significant monetary damages. However, BD gained 510(k) clearance from the FDA for its updated BD Alaris infusion system in 2023, which enabled both remediation and a return to market for the system. The relaunch of the Alaris infusion pump boosted the top line by nearly 50 basis points in 2024. Any setback to the pump may lead to a loss of sales going forward.
Reason for the BD's Recall
The recall stems from software issues in BD’s Alaris Systems Manager and BD Care Coordination Engine Infusion Adapter. These programs are critical components that integrate BD’s Alaris infusion pump with hospital electronic medical record systems. Customer reports indicated delayed system responses and a backlog of automated programming requests (APRs), which could result in incorrect therapy administration. This malfunction creates a risk of patients receiving incorrect medication doses, volumes, or infusion rates, potentially leading to severe complications.
Affected BD Systems
The recall specifically affects BD’s Alaris Systems Manager and BD Care Coordination Engine Infusion Adapter, both of which are essential for optimizing the functionality of the Alaris infusion pump. The Alaris pump is widely used to administer essential fluids, including medications and blood products, in a controlled manner. The software glitches could lead to unexpected pump stoppages, inaccurate drug dosing and adverse patient outcomes. BD and its CareFusion subsidiary have advised healthcare facilities to take precautionary steps, such as manually verifying parameters before initiating therapy and notifying BD if affected software is in use.