TL;DR
The FDA has issued an Early Alert after Cardinal Health told affected customers that some Presource kits contain BD Alaris Pump Infusion Sets covered by a recall. Customers are advised to identify affected kits, review BD’s updated performance disclosures and follow risk-mitigation instructions; the FDA says it is still reviewing the issue.
The FDA has issued an Early Alert after Cardinal Health notified customers that some Presource kits contain BD Alaris Pump Infusion Sets covered by a separate recall. Cardinal Health recommends that affected customers identify the kits, review BD’s updated performance disclosures and adjust clinical use, set selection or pump use as needed; the FDA describes the issue as potentially high risk and says its review is ongoing.
The FDA says Cardinal Health sent a letter to affected customers on September 23, advising that certain Presource convenience kits may include infusion sets covered by the recall titled “BD and CareFusion 303, Inc. Remove BD Alaris Pump Infusion Sets.” The alert identifies Presource Kits as the affected product category and directs users to the full affected-product list and the companies’ customer materials.
For next steps, the FDA says customers should identify affected product in inventory and review the Pump Infusion Set Performance Disclosures in Attachment B of BD’s customer letter. BD’s letter recommends adjusting clinical use, set selection or pump use where appropriate. If the performance of an Alaris pump with an identified set is not clinically appropriate, the letter advises using an alternative pump, such as the BD Alaris Syringe Module or another syringe pump when the module is unavailable.
If no syringe pump is available, BD’s guidance says recalled infusion sets may be used with caution, enhanced clinical monitoring and adherence to previously communicated warnings. The FDA also directs users to risk-mitigation steps in versions 12.3 through 12.6 of the BD Alaris Infusion System User Manual. These include positioning solution containers within specified height limits, checking tubing and clamps when loading a set, and taking precautions when responding to an occlusion. The alert does not say that every Presource kit contains an affected set.
Infusion Accuracy and Alarm Risks
The concern is that revised performance data may affect how accurately an infusion is delivered and how reliably the pump signals a blockage. The FDA says BD’s testing found that previously stated performance was overestimated in some cases, with some infusion performance significantly worse than previously communicated. The potential effects described include under- or over-infusion, delayed occlusion alarms and inaccuracies in bolus doses.
The FDA says deviations most commonly occur at programmable rates below 1 mL per hour and at or below 5 mL of bolus volume. It warns that these issues may not be readily detected by users. The agency says outcomes depend on multiple factors, but the risks may be more serious for vulnerable patients, including neonates, children and critically ill people who may receive low-rate or low-volume infusions of medicines such as antiarrhythmics or blood-pressure-supporting drugs.
The alert matters to hospitals and clinical teams because the affected sets may be bundled inside procedure-specific kits rather than stored as standalone products. Inventory checks and review of the customer letter can help facilities determine whether they have the affected kits and which instructions apply. The FDA’s alert does not establish that harm has occurred at any particular facility.
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How the Kit Alert Relates to BD’s Recall
Presource kits are convenience kits packaged for use during a single surgical or medical procedure. The FDA describes them as containing various instruments, dressings, materials or pharmaceutical components. In this alert, the concern is that some kits may contain BD Alaris Pump Infusion Sets included in BD’s recall, rather than an assertion that every item in a Presource kit is affected.
The FDA links the issue to BD’s continuing testing of Alaris infusion sets. According to the agency’s account of BD’s disclosures, certain restrictive set features—such as closed male luer components, filters, check valves, Y-sites and microbore tubing—can be associated with poorer performance than previously reported. BD’s updated testing found that prior performance claims had been overstated in some instances.
The FDA says its Center for Devices and Radiological Health issued the Early Alert to notify the public of a potentially high-risk device issue. The agency also points readers to BD’s customer letter dated August 19, 2026, and to its separate recall information. As of that date, the FDA report says BD had not reported serious injuries or deaths associated with the issue; that statement reflects the report’s stated status and is not a finding that no harm is possible.
“Previously claimed performance was overestimated, and, in some instances, infusion performance is significantly worse.”
— BD, as described by the FDA
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Affected Kits and Clinical Impact
The FDA alert does not state how many Presource kits or customers are affected, nor does the source material provide a complete product-by-product count in the alert text. Customers are directed to the full affected-product list and company letters to determine whether specific inventory is included. It is also not clear from the alert how many affected sets have been used in clinical settings.
The FDA says it is currently reviewing information about the issue. The report notes that BD had not reported serious injuries or deaths as of August 19, 2026, but the alert does not provide a final assessment of the likelihood of harm or specify how many adverse-event reports, if any, are under review. The potential consequences described are risks, not confirmation that those outcomes occurred.
Facilities may need to assess the guidance against the patients, medication and infusion setup involved. The alert does not provide case-specific clinical direction, and it does not say that the same alternative or mitigation is suitable in every circumstance.
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Customer Checks and FDA Updates
Customers should check inventory for affected Presource kits, consult Cardinal Health’s notice and BD’s customer letter, and apply the recommended steps relevant to their equipment and clinical use. The FDA directs U.S. customers with adverse reactions, quality problems or questions to contact their Cardinal Health sales representative.
The FDA says it will update its webpage when significant new information becomes available. Further updates may clarify affected products, performance findings or the status of the agency’s review. Until then, the alert advises users to check the FDA page and follow the applicable instructions and warnings in the BD materials.
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Key Questions
Which products are covered by the FDA alert?
The alert concerns certain Cardinal Health Presource kits that may contain BD Alaris Pump Infusion Sets included in BD’s infusion set recall. It does not say that every Presource kit is affected; customers should check the affected-product list and company notices.
What should a facility do if it has a potentially affected kit?
The FDA says to identify affected inventory and review BD’s Pump Infusion Set Performance Disclosures and customer letter. Those materials describe adjustments to clinical use, set selection or pump use, as well as mitigation steps. Questions about the issue can be directed to a Cardinal Health sales representative.
Why were the instructions updated?
According to the FDA’s summary of BD’s testing, some sets performed worse than previously communicated, and earlier performance claims were overestimated in some instances. The concerns include possible changes to infusion accuracy, time to occlusion alarms and bolus delivery.
Have serious injuries or deaths been reported?
The FDA report says BD had not reported serious injuries or deaths associated with the issue as of August 19, 2026. The agency is still reviewing information, and the alert does not rule out potential harm.
Where will new information be posted?
The FDA says it will update its Early Alert webpage as significant new information becomes available. The page also links to BD’s customer letter, recall information and resources for identifying medical devices.
Source: primary
