FDA Issues Early Alert on Cardinal Health Kits Containing Recalled Infusion Sets
On October 20, 2026, the US Food and Drug Administration issued an Early Alert to warn healthcare providers about Cardinal Health Presource convenience kits containing recalled infusion sets. Cardinal Health sent a letter to affected customers on September 23, 2026, providing updated instructions for kits that include BD Alaris Pump Infusion Sets. Testing by manufacturer BD showed that pumps using these sets may deliver medicine inaccurately, deliver wrong bolus doses, or delay occlusion alarms, which warn when fluid flow is blocked. These deviations happen most often at low rates under 1 mL/h or bolus volumes at or under 5 mL. For vulnerable patients like newborn babies, children, or critically ill adults, these delivery errors may lead to serious injury or death. As of August 19, 2026, BD reported no serious injuries or deaths from this issue. The FDA advised clinicians to check inventory, adjust pump settings, or switch to alternative syringe pumps.
What was announced
The FDA notified the public that Cardinal Health sent updated instructions to customers using Presource convenience kits. Convenience kits are packaged collections of medical supplies, dressings, and tools meant for single medical procedures. Certain Presource kits contain BD Alaris Pump Infusion Sets affected by a prior recall from BD and CareFusion 303, Inc.
Manufacturer BD retested these infusion sets and found that performance was worse than previously stated. Specific restrictive components, such as check valves, filters, closed male luers, and microbore tubing, cause flow errors. These issues create over-infusion, under-infusion, inaccurate bolus doses (a rapid medication boost), and delayed occlusion alarms that signal blocked fluid paths. Deviations occur mainly at flow rates below 1 mL/h and bolus volumes of 5 mL or less.
What it means
Medical staff must inspect inventory to locate affected Presource packages. The FDA advised health professionals to review BD's disclosures and adjust pump use. If pump performance is unsafe for a patient, staff should switch to alternative devices like the BD Alaris Syringe Module. When no alternative syringe pumps are available, clinicians may use the recalled infusion sets with extra monitoring and caution.
Risk mitigation instructions require specific physical setups. Clinicians must avoid hanging fluid containers lower than the pump module or higher than 21 inches above it. When clearing line blockages, staff should turn off fluid flow to the patient and disconnect tubing to relieve pressure. These steps aim to prevent severe harm in high-risk patients, such as infants, who frequently receive low-volume infusions of vital medicines.
What the announcement does not tell us
The announcement does not state how many total Presource kits or infusion sets are affected nationwide. It does not list specific lot numbers or product catalog numbers directly within the alert text. Additionally, the FDA does not mention whether Cardinal Health will offer financial refunds or product replacements for affected inventory. The document also provides no timeline for when permanent replacement sets will be distributed.
How this was written
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Cardinal Health Presource Kits may contain BD Alaris Pump Infusion Sets with Updated Use Instructions.
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