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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#72313E The SmartSite Low Sorbing Infusion Sets are used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein. The SmartSite Low Sorbing set is comprised of components commonly found on intravascular administration sets and extension sets. It includes a 1.2 micron filter, needleless SmartSite connector, low sorbing tubing segment, pinch clamps, and luer connectors.
Recall Number Z-2279-2013
Classification Class II
Code Info Lot Number 13016314
Product Distributed Qty 600 units
Reason For Recall CareFusion is recalling the SmartSite Low Sorbing Infusion Set, Model 72313E, Lot Number 13016314, because of an incorrect filter was assembled on this lot. The correct filter is a 1.2 micron filter (blue color) but a 0.2 micron filter (clear color) may have been added instead.

Event Detail

Event Id 66150
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 Nationwide Distribution including CA