In a significant regulatory update, BD (Becton, Dickinson and Company) has taken critical steps to ensure patient safety by expanding a Class I recall of its Alaris pump infusion sets. The heightened measures were initiated after internal evaluations revealed risks related to the performance of these pump sets, potentially crucial for patient health. BD remains proactive in addressing these concerns by issuing safety recommendations and corrective actions, thereby sustaining its commitment to medical device quality and patient care.
Extending the Recall
On September 12, 2025, BD expanded its voluntary recall of the Alaris pump infusion sets to include 15 additional models that were previously discontinued. The company advised these sets might still be distributed due to unexpired inventory. Initially started on July 8, 2025, the recall aimed to inform healthcare providers about potential performance deviations, such as bolus dose inaccuracy and alarm delay, associated with the BD Alaris Pump Module model 8100.
Potential Risks and Affected Regions
The company carries concerns about the variances in pump performance, encompassing inaccuracies in flow rate and potential overdose from the post-occlusion bolus volume. Such deviations carry a higher risk for vulnerable groups, notably neonates and critically ill patients, making immediate risk mitigation necessary. Distribution of the affected products included territories in the United States, Canada, Belgium, and South Africa. BD encourages healthcare professionals to consult detailed information available on its website and utilize listed alternatives when required.
– The recall includes 15 additional, previously discontinued infusion sets.
– Discrepancies in operation can lead to serious adverse outcomes for high-risk patients.
– Corrective actions and alternative recommendations have been specified by BD.
– Distribution affected products span multiple regions including North America and Belgium.
BD urges healthcare providers to report adverse events with the affected pumps via the FDA’s MedWatch Program. Such collaborative efforts help mitigate potential risks by allowing a continuous update on the performance of medical devices. While the recall reinforces the importance of vigilance in healthcare settings, it also underscores BD’s unwavering pursuit to enhance medical technology standards and patient outcomes worldwide. With this recall advancing swiftly, BD not only reassures its partners of the safety improvements being implemented but also heralds an environment of trust, acting with transparency and concern for the global health community. The effectiveness of these corrective measures lies in timely communication and persistent adherence to safety protocols, ensuring BD remains a stalwart in supporting medical technology advancements across the globe.
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