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.