The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Recalled Product

  • Alaris System Pump Modules
  • Lot Numbers: All Lots of affected Models
  • Model Number:
    • BD Alaris™ System PC Unit Model 8000, software versions 9.5 and prior
    • BD Alaris™ System PC Unit Model 8015, software versions 9.33 and prior, and software version 12.1.0
    • BD Alaris™ Pump Module Model 8100, software versions 9.33 and prior, and software version 12.1.0.
    • Alaris™ Syringe Module Model 8110, software versions 9.33 and prior, and software version 12.1.0
    • Alaris™ PCA Module Model 8120, software versions 9.33 and prior, and software version 12.1.0
  • Distribution Dates: Alaris PC units with software version 9.33 and older - July 2004 to October 31, 2019; Alaris PC units with software version 12.1.0 December 18, 2019 to January 23, 2020
  • Devices Recalled in the U.S.: 774,000
  • Date Initiated by Firm: February 4, 2020

Device Use

The Alaris System is an infusion pump and vital signs monitoring system. The infusion pumps deliver fluids, medications, blood and blood products into a patient's body in controlled amounts. The pump provides fluids through an infusion tubing set into a patient's vein or through other cleared routes of administration. The system is used in adult, pediatric and neonatal care. The device is used in hospitals and other healthcare facilities.

(Source: Alaris System Instructions for Use, 510(k) K133532)

Reason for Recall

BD/CareFusion 303 is recalling the Alaris Infusion Pump System and Modules due to multiple system errors, software errors, and use-related errors.

For modules with software version 9.33 or earlier, the following issues apply:

  • Software/System errors (System Error 255-xx-xxx)
  • Delay options programming
  • Low battery alarm failures
  • Keep vein open (KVO) / "End of Infusion" alarm priority
  • Use-related errors related to custom concentration programming

For modules with software version 12.1.0, the following issues apply:

  • Low battery alarm failures
  • Keep vein open (KVO)/ "End of Infusion" alarm priority
  • Use errors related to custom concentration programming
  • KVO Rate Not Available When Using Delay Options programming

These errors can lead to delay in infusion, interruption of infusion, slower than expected delivery of medication (under-infusion), and faster than expected delivery of medication (over-infusion).

There have been serious adverse health events with each of these errors. There are 55 reported injuries and one death.

Who May be Affected

  • Health care providers using the Alaris System
  • Patients having infusions using the Alaris System
  • Biomedical Engineering Staff that manage hospital systems

What to Do

On February 4, 2020 BD/CareFusion 303 sent letters to customers, stating the Alaris pump models, issues and the following information:

Contact Information

Consumers with questions may contact BD by phone at (888) 562-6018, Monday through Friday between 7:00am and 4:00pm (Pacific Time) or by emailing SupportCenter@bd.com.

Additional Resources:

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 using an online form, regular mail, or FAX.