CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.
Affected Product
The FDA is aware that Cardinal Health has issued a letter to affected customers recommending updated use instructions for convenience kits containing infusion sets affected by the BD and CareFusion BD Alaris Pump Infusion Set Recall. Affected devices:
What to Do
Identify affected product in inventory. Review the Pump Infusion Set Performance Disclosures provided in the BD customer letter and make any necessary adjustments to clinical use, set selection, or pump use.
On September 23, Cardinal Health sent all affected customers a letter stating certain Presource kits contain BD Alaris Pump Infusion Sets affected by the Infusion Set Recall: BD and CareFusion 303, Inc. Remove BD Alaris Pump Infusion Sets. Cardinal Health recommended that customers review the BD customer letter, which recommends the following actions:
- Review the Pump Infusion Set Performance Disclosures in Attachment B of BD’s customer letter and make any necessary adjustments to clinical use, set selection, or pump use.
- If performance for the BD Alaris Pump with the identified infusion sets is not clinically appropriate, you should use an alternative pump, such as the BD Alaris Syringe Module or an alternative syringe pump if Alaris is not available.
- If no syringe pumps are available, the recalled pump infusion sets may be utilized with caution, enhanced clinical monitoring, and adherence to previously communicated warnings. See Attachment D of BD’s customer letter for Alaris System Label Warnings.
- Implement the Risk Mitigation steps outlined in the v12.3-v12.6 BD Alaris Infusion System User Manual and summarized below:
- Rate and Bolus Accuracy
- Avoid hanging the solution container below the BD Alaris Pump Module, or higher than 21 inches above the top of the BD Alaris Pump Module.
- Time to Alarm (TTA)
- When loading the set, ensure that tubing is directly over the pressure sensors.
- Ensure that all clamps are open; there are no kinks or collapses in the tubing outside of the pump; drops are flowing in the drip chamber. Ensure that the vent is open if applicable.
- Do not use Selectable pressure mode with a setting above 50 mmHg for rates less than 10 mL/h.
- Post Occlusion Bolus Volume (POBV)
- When addressing an occlusion (clearing) ensure that the fluid flow to the patient is OFF.
- Disconnect the tubing to relieve excess pressure through a stopcock if present. Weigh the risks of disconnection with the risks of an unintended bolus.
- Rate and Bolus Accuracy
Check this web page for updates. The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.
Reason for Alert
Cardinal Health stated that certain Presource Kits may contain BD Alaris Pump Infusion Sets affected by Infusion Set Recall: BD and CareFusion 303, Inc. Remove BD Alaris Pump Infusion Sets.
BD stated that some Alaris Pump sets with restrictive components and designs (such as closed male luer, filters, check valves, Y-sites, microbore tubing, etc.) perform worse than previously disclosed. The deviations most commonly occur at low programmable rates under 1 mL/h and at or under 5 mL of “bolus volume”.
BD has continued to test BD Alaris Pump Infusion Sets to update infusion set performance data for accuracy. This testing found that the previously claimed performance was overestimated, and, in some instances, the infusion performance is significantly worse.
Performance attributes that differ from previously communicated values have the potential to result in greater degrees of under- or over-infusion, delayed time to occlusion alarms, and bolus dose inaccuracies. These examples of performance issues may not be readily detected by users.
The severity and nature of the outcomes resulting from this communicated performance depend on various factors but, for the most vulnerable, high-risk populations (i.e., neonates, pediatrics, critically ill patients), could result in serious adverse events or death, as these higher risk patients are more likely to receive lower rate and/or lower volume infusions, such as antiarrhythmics or blood-pressure supporting medications.
As of August 19, 2026, BD has not reported any serious injuries or deaths associated with this issue.
Device Use
Convenience kits contain various instruments, dressings and/or other materials, and pharmaceutical components that are intended to be used during various procedures. Presource kits are packaged together to be used to facilitate a single surgical or medical procedure.
Contact Information
Customers in the U.S. with adverse reactions, quality problems, or questions about this issue should contact their Cardinal Health sales representative.
Additional FDA Resources
Additional Company Resources
Company-provided information is posted here by the FDA as a public service.
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.