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U.S. Department of Health and Human Services

Enforcement Report - Week of August 1, 2012

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Event Detail

Event ID 62007
Product Type Devices
Status Ongoing
Recalling Firm CareFusion 303, Inc.
City San Diego
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-05-25
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern US Nationwide Distribution

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Alaris PC unit model 8015 Product Usage: The device is labeled for prescription use only. not available Class I The recall was initiated because the Alaris PC unit model 8015 has a component on the PC unit power supply board that is causing an error code(120.4630) "System Error" or "Missing Battery Error" at start up. The error code is accompanied by both an audible alarm and visual error messages on the PC unit screen. 112,912 units total (106,888 units in US) Z-2076-2012
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