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The FDA issued an Early Alert after Cardinal Health told affected customers that some Presource kits may 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 U.S. Food and Drug Administration has issued an Early Alert after Cardinal Health told affected customers that certain Presource procedure kits may contain BD Alaris Pump Infusion Sets covered by a separate recall. The alert advises health care facilities to identify affected products and review revised instructions because updated testing found that some sets may perform worse than previously communicated, potentially affecting infusion delivery and alarms.
The FDA says Cardinal Health sent a letter to affected customers on September 23, recommending updated use instructions for convenience kits containing sets included in the recall, titled “BD and CareFusion 303, Inc. Remove BD Alaris Pump Infusion Sets.” The affected product category listed in the alert is Presource Kits. The source material does not provide the full product list, so facilities are directed to check the FDA’s linked affected-product information and identify relevant inventory.
Customers are advised to review Attachment B of BD’s customer letter, which contains Pump Infusion Set Performance Disclosures, and make adjustments to clinical use, set selection or pump use as appropriate. If the documented performance is not clinically appropriate, BD recommends an alternative pump, such as the BD Alaris Syringe Module or another syringe pump. If no syringe pump is available, the affected sets may be used only with caution, enhanced clinical monitoring and adherence to previously communicated warnings, according to the FDA’s summary of BD’s recommendations.
The alert also summarizes risk-reduction steps in the v12.3-v12.6 BD Alaris Infusion System User Manual. These include placing solution containers no higher than 21 inches above the top of the pump module, checking that tubing sits over pressure sensors and that clamps are open, and avoiding specified pressure-mode settings at low infusion rates. When clearing an occlusion, staff are instructed to stop fluid flow to the patient and consider relieving excess pressure through a stopcock, while weighing the risks of disconnecting the line against the risk of an unintended bolus.
Potential Risks in Infusion Delivery
The alert concerns how accurately medication or fluids are delivered by an infusion pump and how quickly the system detects an obstruction. The FDA says performance differences may contribute to under-infusion, over-infusion, delayed occlusion alarms or inaccurate bolus doses. It also cautions that these effects may not be readily detected by users, which makes the revised disclosures and operating precautions relevant to clinical teams assessing whether a particular set and pump are suitable for a patient.
The agency identifies neonates, children and critically ill patients as especially vulnerable because they are more likely to receive low-rate or low-volume infusions, including some medicines that support heart rhythm or blood pressure. The FDA says potential outcomes for these higher-risk patients could include serious adverse events or death. That statement describes a potential risk, not a report that such harm has occurred in this case.
For hospitals and other facilities, the immediate operational issue is to locate affected kits and determine whether their contents remain appropriate for planned use. The recommendations leave clinical decisions to the care setting, guided by BD’s performance disclosures, the patient’s needs and available equipment. The alert does not instruct facilities to discard every Presource kit; it calls for identification, review and appropriate mitigation.
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How the Kit Alert Connects to the Recall
Presource kits are packaged convenience kits that may contain instruments, dressings, other materials or pharmaceutical components intended to support a medical or surgical procedure. The FDA says some kits contain BD Alaris Pump Infusion Sets affected by the separate infusion-set recall. The Cardinal Health notice therefore addresses kits that may include the affected component, while the underlying performance concern relates to the infusion sets used with BD Alaris pumps.
According to the FDA’s account of BD’s findings, some sets with restrictive components or designs—such as closed male luers, filters, check valves, Y-sites or microbore tubing—performed worse than previously disclosed. Deviations were most commonly found at programmable rates below 1 mL per hour and at or below 5 mL of bolus volume. BD said its continued testing found earlier performance claims had been overestimated and that performance was significantly worse in some instances.
The FDA labels its notice an Early Alert for a potentially high-risk device issue and says it is reviewing information. Its source material points to a BD customer letter dated August 19, 2026, and a separate FDA recall resource dated October 5, 2026. The alert does not establish that every Presource kit contains an affected set; the issue is limited to certain kits and products identified through the company and FDA notices.
“Testing found that previously claimed performance was overestimated and, in some instances, infusion performance was significantly worse.”
— BD, as summarized by the FDA
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Affected Kits and Outcomes Still Under Review
The FDA alert does not state how many kits or facilities are affected, and the supplied material does not include the complete product list or identifying lot details. Facilities must use the FDA’s affected-product listing and company notices to determine whether specific inventory is involved. It is also not clear from the alert how many affected kits remain in circulation or how many have been identified by customers.
The FDA says BD had reported no serious injuries or deaths associated with this issue as of August 19, 2026. That is a date-specific statement and does not establish whether any reports have been received since then. The FDA describes possible device-performance effects and potential outcomes for vulnerable patients, but the alert does not report a confirmed patient injury tied to the issue.
The notice also does not quantify how often the performance deviations occur across all affected sets or specify a single clinical response suitable for every patient and procedure. The agency says it is continuing to review information, so its current guidance and product details may change.
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Inventory Checks and FDA Updates
Health care customers should identify Presource kits in their inventory, compare them with the affected-product information and review the BD customer letter’s performance disclosures. They should then follow the risk-mitigation steps and determine, within their clinical processes, whether an alternative pump or additional monitoring is appropriate. The FDA directs U.S. customers with questions, adverse reactions or quality concerns to contact their Cardinal Health sales representative.
The FDA says it will update the Early Alert page as significant new information becomes available. Facilities should check that page and the linked BD recall materials for current product identification and instructions. The agency’s review remains ongoing; no further findings or timeline for its next update are stated in the supplied alert.
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Key Questions
Which products are covered by the alert?
The alert names certain Cardinal Health Presource kits that may contain BD Alaris Pump Infusion Sets covered by the separate recall. It does not say every Presource kit is affected. Customers should check the FDA’s affected-product list and Cardinal Health and BD notices for product-specific details.
What should a facility do with potentially affected kits?
Identify relevant inventory and review the BD customer letter and its performance disclosures. The FDA’s summary says customers should adjust clinical use, set selection or pump use as needed and apply the listed mitigation steps. Questions or quality concerns can be directed to a Cardinal Health sales representative.
Does the alert say that all affected sets must be discarded?
No. The alert summarizes conditional recommendations: use an alternative pump if the set’s performance is not clinically appropriate, or, when no syringe pump is available, use the affected set only with caution, enhanced clinical monitoring and the stated warnings. Clinical teams should consult the full company instructions.
Have injuries or deaths been reported?
The FDA says BD had reported no serious injuries or deaths as of August 19, 2026. That statement is limited to the date given; the alert does not provide a later count or report a confirmed injury related to the issue.
Why can the infusion-set performance issue matter?
The FDA says some sets may deliver fluid differently than previously disclosed, potentially leading to under- or over-infusion, delayed alarms or inaccurate bolus doses. It highlights possible risks for patients receiving low-rate or low-volume infusions, while noting that outcomes depend on multiple factors.
Source: primary
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