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U.S. Department of Health and Human Services

Enforcement Report - Week of July 24, 2013

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Event Detail

Event ID 65664
Product Type Devices
Status Ongoing
Recalling Firm KooJoo Trading Company
City Gimpo City, Gyeongki-Do
State
Country KR
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-07-03
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern US Distribution GA only.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Safety Lancets - Odyssey, Button Activated; Tri- Bevel Tip for Virtually Painless Sampling; Needle automatically retracts, No lancing device required. 26G - Single Use Only, Made In Korea Distributed by Hummingbird Medical, Savannah, GA 100 count Boxes; 40 boxes per case Blood collection by penetrating skin with needle. Lot # HBM1303-4886, Exp 3/6/2016; Lot# HBM1303-4886, Exp 3.6 to 3/21/2016; Lot# HBM1201-02, Exp 1/16/2015; Lot# HBM1203-02, Exp 4/5/2015 Class II Lancets were not sterilized within the dose range established by sterilization validation. 7, 712, 000 pieces (1928 cartons) Z-1729-2013
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