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Early Alert: Cardinal Health Issues Correction for Presource Packs Containing BD Alaris Pump Infusion Sets
The FDA is aware that Cardinal Health has issued a letter to affected customers recommending all convenience kits containing infusion sets affected by the BD and CareFusion BD Alaris Pump Infusion Set Recall be corrected prior to continued use. The recalled device can lead to unpredictable pump behavior, such as under- or over-infusion or failure to infuse, that may lead to severe adverse events. The severity and nature of the outcome may depend on various factors, especially in the most vulnerable and high-risk populations (such as neonates, pediatrics and critically ill patients).
As of August 19, 2026, BD has not reported any serious injuries or deaths associated with this issue.
Questions?
Customers in the U.S. with questions about this recall should contact Cardinal Health Quality Systems at (800) 292-9332.
CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.
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