BEUDAMED
    FDA Enforcement Class II Terminated

    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: Z-1729-2013 · Reported July 24, 2013

    Enforcement

    Recall Number
    Z-1729-2013
    Event ID
    65664
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    KooJoo Trading Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 24, 2013
    Initiation Date
    July 3, 2013
    Classification Date
    July 12, 2013
    Termination Date
    March 13, 2015
    Address
    116-7 Songma-li, Daegoj-myun, N/A, Gimpo City, Gyeongki-Do, N/A, N/A, Korea, Republic Of (South)

    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.

    Reason

    Lancets were not sterilized within the dose range established by sterilization validation.

    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

    Distribution

    US Distribution GA only.

    Quantity

    7, 712, 000 pieces (1928 cartons)