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U.S. Department of Health and Human Services

Enforcement Report - Week of April 24, 2013

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Product Detail

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
Recall Number Z-1112-2013
Classification Class II
Code Info not available
Product Distributed Qty 4,090 total units
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 set while programming a bolus dose.

Event Detail

Event Id 64653
Product Type Devices
Status Ongoing
Recalling Firm Carefusion Corporation
City San Diego
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-03-06
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution USA Nationwide and the countries of Australia and Canada.
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