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U.S. Department of Health and Human Services

Class 2 Device Recall Odyssey

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  Class 2 Device Recall Odyssey see related information
Date Initiated by Firm July 03, 2013
Date Posted July 13, 2013
Recall Status1 Terminated 3 on March 13, 2015
Recall Number Z-1729-2013
Recall Event ID 65664
Product Classification Lancet, blood - Product Code FMK
Product 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.
Code Information 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
Recalling Firm/
Manufacturer		 KooJoo Trading Company
116-7 Songma-li, Daegoj-myun
Gimpo City, Gyeongki-Do Korea, Republic Of (South)
For Additional Information Contact Heegon Kim
267-2109365
Manufacturer Reason
for Recall		 Lancets were not sterilized within the dose range established by sterilization validation.
FDA Determined
Cause 2		 Process control
Action The firm, KooJoo, sent a "MEDICAL DEVICE VOLUNTARY T RECALL" letter dated July 3, 2013 via first class mail to its customer. The letter described the product, problem and actions to be taken. The customer was instructed to identify and hold all safety lancets you have in inventory that was received before June 2013; notify your retail customers of this product recall and complete and return the attached Customer Reply Form via email to heegonkim@hotmail.com and also return form along with any unused/undistributed product for replacement. If you have further questions, please email heegonkim@hotmail.com or call 209-403-9191 during 9:00am to 5:00pm M-F PST.
Quantity in Commerce 7, 712, 000 pieces (1928 cartons)
Distribution US Distribution GA only.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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