Home / Recalls / Carefusion Corporation / Z-1112-2013

Z-1112-2013 Class II Terminated

Recalled by Carefusion Corporation — San Diego, CA

Recall Details

Product Type: Devices
Report Date: April 24, 2013
Initiation Date: March 6, 2013
Termination Date: May 8, 2014
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 4,090 total units

Product Description

Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System

Reason for Recall

The recall was initiated because Carefusion has identified potential risk associated with bolus programming with the Alaris PC unit (model 8015) software version 9.12. Automating infusion pump parameter input from either the electronic medical record (EMR) or the Alaris Auto-ID module for a continuous infusion with a bolus dose option may result in a loss of information from the Guardrails Data s

Distribution Pattern

Worldwide Distribution USA Nationwide and the countries of Australia and Canada.

Code Information

not available