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The FDA issued an Early Alert after Cardinal Health advised customers that some Presource kits may contain BD Alaris Pump Infusion Sets covered by a separate recall. Customers are instructed to quarantine affected kits, alert clinicians and label kits so the recalled sets are removed and discarded before use. The FDA says it is reviewing the issue; BD had reported no serious injuries or deaths as of August 19, 2026.
The U.S. Food and Drug Administration has issued an Early Alert after Cardinal Health told affected customers to correct certain Presource convenience kits that may contain BD Alaris Pump Infusion Sets included in a separate recall. The agency says the affected sets can malfunction, potentially causing under-infusion, over-infusion or failure to infuse, and advises facilities to quarantine affected kits and remove and discard the recalled components before use.
According to the FDA, Cardinal Health’s September 24 customer letter recommends that customers locate and quarantine affected kits, alert clinicians, and attach a clearly visible warning label to the front of each kit. The label should instruct clinicians to remove and discard the recalled BD Alaris infusion set included in the kit. Cardinal Health says facilities can request additional labels by emailing gmb-FieldCorrectiveAction@cardinalhealth.com.
The alert concerns Presource kits, which package instruments, dressings, other materials or pharmaceutical components for use in a medical or surgical procedure. The FDA says certain kits may contain sets covered by the BD and CareFusion 303, Inc. infusion set recall. The FDA page links to a full list of affected devices, but the supplied alert text does not enumerate individual kit identifiers or quantities.
The FDA describes the issue as potentially high risk and says it is reviewing information. The agency warns that unpredictable pump behavior may lead to severe adverse events; the possible outcome can depend on factors including the patient’s condition, with neonates, children and critically ill patients identified as especially vulnerable groups. The alert states that BD had not reported serious injuries or deaths associated with the issue as of August 19, 2026. That statement is limited to the date and reporting described by the agency.
Keeping Recalled Sets Out of Use
A Presource kit may be opened for a procedure with its contents treated as a ready-to-use group. If a recalled infusion set remains inside, clinicians may not recognize the component’s recall status before connecting it to an infusion pump. The FDA advises facilities to quarantine affected kits and place a visible warning on them before use.
An infusion set malfunction could affect whether a patient receives the intended amount of fluid or medication, or receives any infusion. The FDA warns of possible under- or over-infusion and failure to infuse, but the alert does not provide case details or quantify how often these outcomes have occurred. The agency identifies vulnerable patients, including neonates, children and critically ill patients.
The notice asks hospitals and other customers to identify affected kits, segregate them, communicate the instructions to clinicians and apply the warning label. Distributors that passed affected kits to other customers are asked to notify those customers. The alert does not say that every Presource kit or every BD Alaris set is affected, so facilities should use the product information and affected-device list to determine which items are covered.
BD Alaris Pump Infusion Sets recall
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How the Kit Correction Relates to BD’s Recall
This FDA notice is a correction involving Cardinal Health’s Presource kits, rather than a statement that all Presource products have the same issue. Cardinal Health’s concern, as described by the agency, is that some kits contain individual infusion sets covered by the BD and CareFusion 303, Inc. recall. The requested correction is to remove the recalled component from the kit and warn users, not to continue using that component.
The FDA points readers to a separate recall resource titled “Infusion Set Recall: BD and CareFusion 303, Inc. Remove BD Alaris Pump Infusion Sets,” dated October 5, 2026, and to BD’s customer letter dated August 19, 2026. The agency’s alert says Presource kits are intended to facilitate a single procedure by grouping supplies together. That packaging can make a component-level recall relevant to facilities that received the set as part of a kit rather than as a separately purchased item.
The FDA says it will update its Early Alert page as significant new information becomes available. The agency also provides a U.S. customer contact for questions or reports: Cardinal Health Quality Systems at (800) 292-9332. Health professionals and consumers may report adverse reactions or quality problems through the FDA’s MedWatch program.
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Affected Kit Scope Still Needs Checking
The alert text supplied by the FDA does not state how many kits or facilities are affected, provide a complete list of product identifiers, or describe the geographic distribution. Customers need to consult the FDA’s full affected-device list and Cardinal Health’s communications to confirm whether specific inventory is included. The notice does not say that all Presource kits contain the recalled sets.
The FDA says it is still reviewing information and plans to update its page when significant new information becomes available. The alert does not give a confirmed malfunction rate, explain how many sets have been used, or describe any individual adverse-event reports. BD’s statement about serious injuries and deaths is dated August 19, 2026; the supplied material does not provide a later tally or independent outcome assessment.
It is also not clear from the alert whether every affected kit has already been located and corrected, how quickly replacement components may be available, or whether additional product groups will be added. Those details should not be inferred from the warning alone.
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Facilities Should Verify and Report
Facilities should compare their Presource inventory with the FDA’s affected-device information and Cardinal Health’s customer notice. If a kit is covered, the company’s instructions are to quarantine it, notify clinicians and apply the visible warning label directing removal and disposal of the recalled infusion set before the kit is used. Distributors that further distributed affected kits are asked to notify their customers. Facilities needing labels may contact Cardinal Health at the email address provided in the alert.
Customers in the United States with questions, quality concerns or adverse reactions can contact Cardinal Health Quality Systems at (800) 292-9332. The FDA also directs health professionals and consumers to MedWatch for reports of adverse reactions or quality problems. The agency says it will post updates as its review continues; no further FDA action date or company correction deadline is given in the supplied material.
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Key Questions
Which products are covered by the alert?
The alert concerns certain Cardinal Health Presource kits that may contain BD Alaris Pump Infusion Sets covered by the BD and CareFusion 303, Inc. recall. It does not say that every Presource kit is affected. Customers should check the FDA’s affected-device list and Cardinal Health’s notice against their inventory.
What should a facility do with an affected kit?
Cardinal Health’s instructions, as reported by the FDA, are to locate and quarantine the kit, alert clinicians and attach a visible warning telling them to remove and discard the recalled infusion set before use. The affected set should not be used as part of the kit.
What could happen if a recalled set malfunctions?
The FDA says the set may cause unpredictable pump behavior, including under-infusion, over-infusion or failure to infuse, which could lead to severe adverse events. The agency says outcomes may depend on the circumstances and identifies neonates, children and critically ill patients as vulnerable groups.
Have injuries or deaths been reported?
The FDA alert says BD had not reported serious injuries or deaths associated with the issue as of August 19, 2026. The alert does not provide a later report or a complete account of other possible events, and the FDA says its review is ongoing.
Where can customers get help or report a problem?
U.S. customers can contact Cardinal Health Quality Systems at (800) 292-9332. Facilities can request additional labels by emailing gmb-FieldCorrectiveAction@cardinalhealth.com. The FDA says adverse reactions or quality problems may also be reported through MedWatch.
Source: primary
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