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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 64321
Product Type Devices
Status Ongoing
Recalling Firm Greiner Bio-One North America, Inc.
City Monroe
State NC
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-02-01
Initial Firm Notification of
Consignee or Public
Distribution Pattern US Nationwide Distribution in the states of FL, IL, KY, NY, NC, PA, OH, TX, VA

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
VACUETTE Safety Blood Collection Set + Luer Adapter, 23x12" Safety Blood Collect LA Product, Item number 450096. Usage: The Safety Blood Collection Set is used in routine venipuncture procedures. Lot No. 12H27 Class II The VACUETTE Safety Blood Collection Set + Luer Adapter may display leaking (small droplets) during use due to a crack on the luer connector piece. 192,000 pieces (192 cases) Z-0835-2013