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U.S. Department of Health and Human Services

Enforcement Report - Week of April 24, 2013

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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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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 not available Class II 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. 4,090 total units Z-1112-2013
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