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U.S. Department of Health and Human Services

Enforcement Report - Week of July 24, 2013

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Product Detail

Product Description 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.
Recall Number Z-1729-2013
Classification Class II
Code Info 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
Product Distributed Qty 7, 712, 000 pieces (1928 cartons)
Reason For Recall Lancets were not sterilized within the dose range established by sterilization validation.

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.
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