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U.S. Department of Health and Human Services

Enforcement Report - Week of February 27, 2013

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Event Detail

Event ID 64204
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 2012-12-20
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide Distribution including the states of AK, CA, CO, IL, MO, NV, NY, TX and UT.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
CareFusion SmartSite Gravity Blood Set Model 42082E. Used to administer blood and blood products through a needle or catheter inserted into the patient's artery or vein. Lot number 12055225 Class II CareFusion is recalling the SmartSite® Gravity Blood Set as a result of a potential for separation at the connection of the drip chamber and tubing . The separation may be observed at priming or observed during use. If a separation between the drip chamber and tubing occurs, this could cause a delay in treatment. 5,050 units Z-0832-2013