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 all convenience kits containing infusion sets affected by the BD and CareFusion BD Alaris Pump Infusion Set Recall be corrected prior to continued use. The affected infusion pump sets may result in malfunctions that can lead to unpredictable pump behavior (i.e., under- over-infusion or failure to infuse) that may lead to severe adverse events. Affected devices:
What to Do
Locate and quarantine affected kits. Affix a warning label instructing clinicians to remove and discard the recalled BD Alaris Pump Infusion sets included in the kit.
On September 24, Cardinal Health sent all affected customers a letter recommending the following actions:
- Locate and quarantine affected kits.
- Alert clinicians of this action.
- Affix a warning label to the front of each Presource kit so that it is clearly visible to clinicians, instructing them to remove and discard the recalled component(s).
- Additional labels will be sent to your facility upon request. Please send an email to: [email protected].
- If you are a Distributor and have further distributed affected kits please notify your customers of this recall.
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.
The recalled device can lead to unpredictable pump behavior, such as under- or over-infusion or failure to infuse, that may lead to severe adverse events. The severity and nature of the outcome may depend on various factors, especially in the most vulnerable and high-risk populations (such as neonates, pediatrics and critically ill patients).
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 Cardinal Health Quality Systems at (800) 292-9332.
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.