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Early Alert: Cardinal Health Updates Use Instructions for Presource Packs Containing BD Alaris Pump Infusion Sets 

The FDA is aware that Cardinal Health has issued a letter to affected customers recommending updated use instructions for convenience kits containing infusion sets affected by the BD and CareFusion BD Alaris Pump Infusion Set Recall. 

BD stated that some Alaris Pump sets with restrictive components and designs (such as closed male luer, filters, check valves, Y-sites, microbore tubing, etc.) perform worse than previously disclosed. The deviations most commonly occur at low programmable rates under 1 mL/h and at or under 5 mL of “bolus volume”. 

BD has continued to test BD Alaris Pump Infusion Sets to update infusion set performance data for accuracy. This testing found that the previously claimed performance was overestimated, and, in some instances, the infusion performance is significantly worse. 

Performance attributes that differ from previously communicated values have the potential to result in greater degrees of under- or over-infusion, delayed time to occlusion alarms, and bolus dose inaccuracies. These examples of performance issues may not be readily detected by users. 

The severity and nature of the outcomes resulting from this communicated performance depend on various factors but, for the most vulnerable, high-risk populations (i.e., neonates, pediatrics, critically ill patients), could result in serious adverse events or death, as these higher risk patients are more likely to receive lower rate and/or lower volume infusions, such as antiarrhythmics or blood-pressure supporting medications. 

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 their Cardinal Health sales representative.

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.