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The FDA issued an Early Alert after Cardinal Health told affected customers that some Presource convenience kits may contain BD Alaris pump infusion sets covered by a recall. The companies’ instructions call for identifying affected kits, reviewing updated performance information and considering changes to set selection or pump use; the FDA says it is reviewing the issue.
The U.S. Food and Drug Administration has issued an Early Alert after Cardinal Health advised customers that certain Presource kits may contain BD Alaris pump infusion sets covered by a separate recall. Cardinal Health recommended that affected customers identify the kits and review updated performance information and risk-mitigation instructions before deciding how to use the sets.
The FDA says Cardinal Health sent a letter to affected customers on September 23, explaining that certain Presource kits contain BD Alaris Pump Infusion Sets affected by the recall identified as “Infusion Set Recall: BD and CareFusion 303, Inc. Remove BD Alaris Pump Infusion Sets.” Presource kits are packaged collections of materials intended to support a medical or surgical procedure. The alert names Presource Kits as the affected product category; the full product list is linked from the FDA notice.
Cardinal Health recommended that customers locate affected products in their inventory and consult the performance disclosures in Attachment B of BD’s customer letter. The FDA notice says customers should make any necessary adjustments to clinical use, infusion-set selection or pump use based on that review. If the disclosed performance is not clinically appropriate, BD recommends using an alternative pump, such as the BD Alaris Syringe Module or another syringe pump if an Alaris module is unavailable.
If no syringe pump is available, the notice says the recalled infusion sets may be used with caution, enhanced clinical monitoring and adherence to previously communicated warnings. It also points users to risk-mitigation steps in versions 12.3 through 12.6 of the BD Alaris Infusion System User Manual. These include keeping solution containers within specified height limits, checking tubing placement and flow, following restrictions on selectable pressure mode at low flow rates, and taking precautions when clearing an occlusion to reduce the risk of an unintended bolus.
Risks for Low-Rate Infusions
The alert concerns the accuracy and timing of medication delivery by an infusion system, not just the presence of a particular component in a kit. According to the FDA’s account of BD’s findings, some infusion sets with restrictive components or designs may perform worse than previously disclosed. The reported performance differences could contribute to under- or over-infusion, delayed occlusion alarms or inaccurate bolus doses, and the FDA says users may not readily detect some of these problems.
BD’s disclosures describe the most common deviations at programmable rates below 1 mL per hour and at or below 5 mL of bolus volume. The FDA says potential consequences depend on the circumstances, but could be serious for vulnerable patients, including neonates, children and critically ill people who may receive low-rate or low-volume infusions. The alert gives examples of medications used to treat heart rhythm problems or support blood pressure. This makes checking inventory and clinical suitability relevant to hospitals and other providers that use the kits.
The notice does not say every affected set will cause a delivery problem, nor does it report that a specific patient was harmed. It is a public warning about a potentially high-risk device issue while the FDA reviews information. Following the stated instructions may help providers assess the risk, but the alert leaves product-specific decisions to the applicable performance disclosures and clinical circumstances.
BD Alaris infusion set replacement
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How the Kit Alert Connects to the Recall
The FDA’s Early Alert links Cardinal Health’s customer notice to an earlier BD and CareFusion 303, Inc. recall involving BD Alaris pump infusion sets. The alert says affected Presource kits can contain those sets; the kit notice does not describe a separate, unrelated pump issue. Rather, it advises kit customers to apply the information and precautions associated with the infusion-set recall.
BD has continued testing infusion-set performance, according to the FDA notice. That testing found that previously stated performance had been overestimated and that performance was significantly worse in some instances. The alert highlights set designs that may include restrictive features such as closed male luer connectors, filters, check valves, Y-sites or microbore tubing. It does not provide a complete item-by-item account of which design features or kit configurations are affected in the text supplied here; the FDA’s linked product list and BD materials are the sources for identifying specific products.
The FDA says that, as of August 19, 2026, BD had not reported serious injuries or deaths associated with the issue. That is a time-specific statement about reports received by BD, not a finding that the risk is absent. The agency says it is reviewing information and will update the alert page when significant new information becomes available.
“Testing found that previously claimed performance was overestimated, and in some instances infusion performance was significantly worse.”
— BD, as described by the FDA
What the Alert Does Not Resolve
The FDA has not said how many Presource kits or individual infusion sets are affected, how widely they have been distributed, or which customers hold them. Readers and providers need to use the full affected-product list and company letters to check specific products rather than assume that every Presource kit is included. The supplied alert text also does not specify a final disposition for every affected set beyond the conditional guidance on alternatives and cautious use.
The notice does not establish how often the performance deviations occur in clinical use or whether a particular infusion has been affected. The possible outcomes are described as risks, and the FDA says their severity depends on multiple factors. The agency’s statement that no serious injuries or deaths had been reported by BD as of August 19 is limited to that date and source; it does not establish that no adverse events have occurred since or that none went unreported.
The FDA says its review is ongoing. Further details about the affected product scope, investigation findings or additional recommended actions may be posted as the agency receives and evaluates information.
Inventory Checks and FDA Updates
Customers should follow the FDA-listed steps: identify potentially affected products in inventory, review BD’s performance disclosures and determine whether clinical use, set selection or pump use needs to change. Providers should refer to the applicable BD letter and the relevant Alaris system manual for the detailed instructions, including the precautions for low flow rates, tubing setup and occlusion response. For product questions or adverse reactions and quality problems in the United States, the FDA notice directs customers to contact their Cardinal Health sales representative.
The FDA says it will keep the alert page updated as significant new information becomes available. Its notice also links to the related infusion-set recall and BD’s customer letter and recall page. The next public development is likely to depend on the agency’s continuing review and any additional information or actions from Cardinal Health or BD; the supplied notice does not give a date for a further update.
Key Questions
Which products are covered by the FDA alert?
The alert identifies certain Cardinal Health Presource kits that may contain BD Alaris Pump Infusion Sets covered by the separate infusion-set recall. It does not say that every Presource kit is affected. Customers should check the full affected-product list linked from the FDA notice.
What should a customer do with a potentially affected kit?
Identify the product in inventory and review the BD performance disclosures and customer letter. The FDA notice says customers should make any necessary changes to clinical use, set selection or pump use in line with that information and the stated risk-mitigation steps.
Does the alert say the infusion sets must never be used?
The notice recommends an alternative pump when the disclosed performance is not clinically appropriate. If no syringe pump is available, it says the recalled sets may be used with caution, enhanced monitoring and the stated warnings. Providers should consult the company instructions and make decisions based on the specific clinical situation.
Have serious injuries or deaths been reported?
The FDA says that, as of August 19, 2026, BD had not reported serious injuries or deaths associated with the issue. That statement is limited to BD’s reports as of that date and does not predict whether later information will change the record.
Where can U.S. customers ask questions or report a problem?
The FDA notice directs U.S. customers with questions, adverse reactions or quality problems to contact their Cardinal Health sales representative. The FDA page also links to BD’s customer letter and recall information.
Source: primary
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