PlainRecalls
FDA Devices Moderate Class II Terminated

Alaris PC unit model 8015, Infusion pump. software version 9.17 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. The software is embedded in the Alaris PC unit.

Reported: June 24, 2015 Initiated: May 13, 2015 #Z-1811-2015

Product Description

Alaris PC unit model 8015, Infusion pump. software version 9.17 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. The software is embedded in the Alaris PC unit.

Reason for Recall

An issue with the cancel functionality used during atypical infusion programming to cancel user inputted values. An infusion may start that is greater than or less than the hospital established limits for the specific medication.

Details

Recalling Firm
CareFusion 303, Inc.
Units Affected
63 units
Distribution
US Nationwide Distribution
Location
San Diego, CA

Frequently Asked Questions

What product was recalled?
Alaris PC unit model 8015, Infusion pump. software version 9.17 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. The software is embedded in the Alaris PC unit.. Recalled by CareFusion 303, Inc.. Units affected: 63 units.
Why was this product recalled?
An issue with the cancel functionality used during atypical infusion programming to cancel user inputted values. An infusion may start that is greater than or less than the hospital established limits for the specific medication.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 24, 2015. Severity: Moderate. Recall number: Z-1811-2015.