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Update on Early Alert: Infusion Set Performance Issue from BD
The FDA is aware that BD and their subsidiary, CareFusion have issued two “Urgent Medical Device Recall (Correction)” letters notifying affected customers of worse performance, under certain use cases, for the BD Alaris Pump Module model 8100 (pump module) when used with a subset of compatible pump infusion sets. The most recent letter includes additional affected devices, corrective actions, and risk information. New or modified information is now available on this Early Alert, marked as “(Updated)” throughout the page.
As of June 11, BD has not reported any serious injuries or deaths associated with this issue.
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. The affected products, recommendations for what to do with the devices, and reason for alert have significant updates.
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact BD Alaris Medical Affairs at alarismedicalaffairs@bd.com or BD’s Technical Support at DL-US-INF-TechSupport@bd.com or 1-888-812-3229.
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