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U.S. Department of Health and Human Services

Enforcement Report - Week of July 11, 2012

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Event Detail

Event ID 62447
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 2012-04-02
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide Distribution including IL, MS, OH, PA, TN and VA.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Vacuette Quickshield Complete Plus, 21G x 1 (0.8 x 25 mm), Greiner bio-one. The Quick shield Complete Plus is intended to be used only with Vacuette Blood collection Tubes as a system in routine venipuncture procedures. They are for single-use only and should only be used by adequately trained healthcare personnel in accordance with instructions for use. Item #450239, Lot #G110601I and Item #450235, Lot #G110302J. Class II : The Quickshield Complete Plus may have a defect (split at the base), which can cause the green safety shield attachment of the Quickshield holder to be loose and unstable. 19.5 cases (5,850 pieces) and 244 cases (73,200 pieces)= 263.5 (73258 pieces total) Z-1935-2012