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U.S. Department of Health and Human Services

Enforcement Report - Week of October 2, 2013

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Event Detail

Event ID 66151
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 2013-08-30
Initial Firm Notification of
Consignee or Public
Distribution Pattern Class II Recall - United States ***Center Recommended Depth - Consumers/Users**

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
SmartSite Low Sorbing Infusion Set, Model# 10015048. Intravascular administration set. Lot Numbers 13015883 and 13025342. Class II CareFusion is recalling the SmartSite Low Sorbing Infusion Set, Model# 10015048, because there is a potential for separation at the tubing sleeve below the drip chamber. 15860 units Z-2285-2013