The Recall Desk
HighFDA (Devices)·Z-1811-2015·Announced 2015-06-24

CareFusion Alaris PC Unit Infusion Pump Software Recall

CareFusion 303, Inc. is recalling 63 Alaris PC unit model 8015 infusion pumps due to a software defect that may allow infusions to start outside hospital-established limits.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device defect that could lead to medication administration outside established safety limits, representing a risk of harm where injury has not yet been reported.

Plain-English summary

CareFusion 303, Inc. is recalling 63 units of the Alaris PC unit model 8015, an infusion pump component, due to a software issue in version 9.17. The Alaris PC unit serves as the central programming, monitoring, and power supply component for the Alaris System.

The recall is issued because of a defect in the cancel functionality used during atypical infusion programming. This issue may allow an infusion to start with values that are greater than or less than the hospital-established limits for the specific medication. The affected units were distributed nationwide in the United States.

Healthcare facilities should check their inventory for the specific serial numbers listed in the recall notice and contact CareFusion 303, Inc. for instructions on how to address the software defect.

The recalled product

Product
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.
Manufacturer
CareFusion 303, Inc.
Category
Medical Device — Infusion Pump
Hazard
Affected units
63

Distribution

Distributed nationwide across the United States.

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