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U.S. Department of Health and Human Services

Enforcement Report - Week of October 2, 2013

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Product Detail

Product Description SmartSite Low Sorbing Infusion Set, Model# 10015048. Intravascular administration set.
Recall Number Z-2285-2013
Classification Class II
Code Info Lot Numbers 13015883 and 13025342.
Product Distributed Qty 15860 units
Reason For Recall 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.

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 Letter
Distribution Pattern Class II Recall - United States ***Center Recommended Depth - Consumers/Users**