Carefusion Infusion Pump Recall Issued Due to Software Problem

About 17,000 CareFusion Alaris PC electronic drug infusion pumps have been recalled due to a software problem that may cause the devices to freeze if they lose their wireless internet connection, potentially causing serious injury and death. 

The FDA issued a notification of the Alaris recall on October 15, categorizing it as a Class I medical device recall; meaning that the agency believes the malfunction is likely to cause serious injury or death in patients. Neither the FDA nor Carefusion Corporation, the manufacturer, indicate that there have been any injuries related to the electronic infusion pump recall.

Electronic infusion pumps inject programmed amounts of drugs and other substances into patients bodies through intravenous, intra-arterial and epidural injections.

Did You Know?

Millions of Philips CPAP Machines Recalled

Philips DreamStation, CPAP and BiPAP machines sold in recent years may pose a risk of cancer, lung damage and other injuries.

Learn More

The Alaris PC Unit’s screen could freeze if it suffers a communication error through its wireless network connection. This can delay therapy and prevent program changes to current infusions. It also means that infusions continue unchanged and cannot be modified. Attempting to stop the pump from delivering drugs to the patient can cause the Alaris to shut down, delaying or interrupting therapy and potentially causing serious injury and/or death.

The infusion pump recall affects about 17,000 Alaris PC Units model 8015 that contain logic boars P.N TC10005522 or TC10005572. A link to the serial numbers of affected units is available here (pdf). The recalled pumps were manufactured or serviced between December 2008 and September 2009.

The company has notified all registered owners and issued a tip sheet on using the units until they can receive a hardware update that will fix the problem. The FDA recommends that any institution or user who experiences the problem should remove the device from service and contact the CareFusion Recall Center immediately at


"*" indicates required fields

Share Your Comments

I authorize the above comments be posted on this page*

Have Your Comments Reviewed by a Lawyer

Provide additional contact information if you want an attorney to review your comments and contact you about a potential case. This information will not be published.

NOTE: Providing information for review by an attorney does not form an attorney-client relationship.

This field is for validation purposes and should be left unchanged.

More Top Stories