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U.S. Department of Health and Human Services

Enforcement Report - Week of April 23, 2014

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Product Detail

Product Description SmartSite Extension Set, Model No. 20029E, intravascular administration set
Recall Number Z-1459-2014
Classification Class II
Code Info Lot No. 13085791
Product Distributed Qty 7,700 units
Reason For Recall CareFusion is recalling the SmartSite Extension Set because there are reports of disconnections and leakages at the connection of the smallbore tubing and the SmartSite Y-port.

Event Detail

Event Id 67774
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 2014-03-19
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern USA Nationwide Distribution in the states of: AR, AZ, CA, CO, FL, ID, MD, MI, NC, NV, OK, OR, PA, TX, VA, WI