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U.S. Department of Health and Human Services

Enforcement Report - Week of February 27, 2013

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Product Detail

Product Description 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.
Recall Number Z-0835-2013
Classification Class II
Code Info Lot No. 12H27
Product Distributed Qty 192,000 pieces (192 cases)
Reason For Recall The VACUETTE Safety Blood Collection Set + Luer Adapter may display leaking (small droplets) during use due to a crack on the luer connector piece.

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 Letter
Distribution Pattern US Nationwide Distribution in the states of FL, IL, KY, NY, NC, PA, OH, TX, VA