FDA Alert Covers Cardinal Health Presource Kits
Cardinal Health Presource kits may include recalled BD Alaris pump infusion sets, according to an October 20, 2026, Early Alert from the U.S. Food and Drug Administration. The components are covered by a separate BD and CareFusion recall. The FDA listed information in the alert as still under review.
Presource kits contain supplies packaged for use in one medical or surgical procedure, according to the FDA. In a September 24, 2026, customer letter, Cardinal Health recommended finding and quarantining affected kits and notifying clinicians. The letter also recommended placing a visible label on each affected kit directing clinicians to take out and discard the recalled infusion set before using the kit.
The FDA’s guidance likewise recommends quarantine and labeling to identify the component that clinicians should remove and discard. For distributors that supplied affected kits to other customers, the agency recommends notifying those recipients. Cardinal Health said facilities can request more labels.
According to the FDA, malfunctioning infusion sets can deliver an insufficient or excessive amount of fluid, or deliver none, with potentially severe adverse events. The agency identifies newborns, children and critically ill patients among groups at higher risk. It says outcomes may vary with the patient’s condition and the medication or fluid being administered.
The FDA’s separate recall information describes several possible performance problems: inaccuracies in flow rates and bolus doses, delays in occlusion alarms, and incorrect bolus volumes after an occlusion. Performance deviations occur more frequently when programmed delivery is below 1 mL per hour or the bolus volume is no more than 5 mL, according to the agency.
In some uses, the FDA associates poorer performance with features including microbore tubing, Y-sites, check valves and filters. The recalled infusion sets work with model 8100 of the BD Alaris Pump Module. The agency identifies the affected system software as BD Alaris with Guardrails Suite MX, covering versions through 12.6.
As of August 19, 2026, BD had reported no serious injuries or deaths connected with the infusion-set issue, according to the FDA. That dated reporting status does not establish that the risk has been eliminated.
* This article is based on publicly available information at the time of writing.