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FDA MedWatch Safety AlertsUnited States20 October 2026

Cardinal Health Presource Kits Corrected Over Recalled BD Alaris Infusion Sets

The U.S. Food and Drug Administration issued an Early Alert on October 20, 2026, regarding Cardinal Health Presource convenience kits. Cardinal Health sent an instruction letter to affected customers on September 24, 2026, recommending a correction for kits that contain recalled BD Alaris Pump Infusion Sets. These medical infusion sets can malfunction and cause unpredictable pump behavior, including over-infusion, under-infusion, or a failure to infuse fluids. Such errors can lead to severe adverse events, particularly for vulnerable patients such as neonates, children, and critically ill individuals. The FDA advises facilities to locate and quarantine affected kits right away. Staff should place visible warning labels on the front of each kit, instructing clinicians to remove and discard the recalled infusion sets before continued use. Distributors must pass this recall notice to their customers. As of August 19, 2026, manufacturer BD has not reported any serious injuries or deaths associated with this issue.

What was announced

The U.S. Food and Drug Administration published an Early Alert regarding a correction issued by Cardinal Health for its Presource convenience kits. Convenience kits pack together medical instruments, dressings, and pharmaceuticals needed for single medical procedures.

Certain Presource kits contain BD Alaris Pump Infusion Sets made by BD and CareFusion 303, Inc. These infusion sets were previously recalled because they can cause pump malfunctions. The FDA stated that Cardinal Health issued a letter to customers on September 24, 2026, asking them to locate and quarantine affected kits. Facilities must apply warning labels to the front of each kit. These labels instruct healthcare workers to remove and discard the recalled infusion components before using the remaining items in the kit. Facilities can request extra labels by emailing Cardinal Health directly.

What it means

Medical staff use infusion pumps to deliver fluids, medications, or nutrients into a patient's body. When the pump set malfunctions, it may deliver too much fluid, too little fluid, or no fluid at all.

Unpredictable dosing creates severe risks. The danger is highest for vulnerable patient groups, including neonates, pediatric patients, and critically ill people. To prevent harm, hospitals and healthcare centers must mark all affected Presource packages clearly. Distributors who resold these kits must also notify their customers about the recall action. As of August 19, 2026, BD reported no serious injuries or deaths linked to this specific flaw.

What the announcement does not tell us

The announcement does not state how many Presource kits or infusion sets are affected by this action. It does not list the specific catalog numbers, lot numbers, or Unique Device Identifiers directly in the text, directing readers to external links instead.

The document does not explain what root cause led to the BD Alaris set malfunctions. It also does not outline how long the labeling and correction process will take across healthcare facilities.

How this was written

This analysis was written with AI from the official announcement below, using only facts that announcement states. The quoted wording is FDA MedWatch Safety Alerts’s own. Always check the original before acting on anything here.

Cardinal Health Presource Kits containing recalled BD Alaris Pump Infusion Sets should be corrected prior to continued use.
Source: FDA MedWatch Safety Alerts

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