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U.S. Department of Health and Human Services

Enforcement Report - Week of December 11, 2013

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Event Detail

Event ID 66759
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 2013-11-08
Initial Firm Notification of
Consignee or Public
Distribution Pattern US Distribution in CA, WY, OH, UT, and MA.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
SmartSite Low Sorbing Infusion Set with Texium Close Male Luer, Model No. 24301-0007T The SmartSite Low Sorbing Infusion Sets with Texium Male Luer are used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein. Lot No: 13046215 13046641 13056285 13056577 13075931 Class II CareFusion is recalling the SmartSite Low Sorbing Infusion Set with Texium Closed Male Luer because it is not assembled with low-sorbing tubing. 480 units Z-0450-2014