BEUDAMED
    FDA Recall 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 · Initiated July 3, 2013

    Recall

    Recall Number
    Z-1729-2013
    Event Number
    65664
    Firm
    KooJoo Trading Company 116-7 Songma-li, Daegoj-myun Gimpo City, Gyeongki-Do Korea, Republic Of (South)
    FEI Number
    3004562367
    Product Code
    FMK
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    July 3, 2013
    Posted
    July 13, 2013
    Terminated
    March 13, 2015

    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.

    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 [email protected] and also return form along with any unused/undistributed product for replacement. If you have further questions, please email [email protected] or call 209-403-9191 during 9:00am to 5:00pm M-F PST.

    Distribution

    US Distribution GA only.

    Quantity

    7, 712, 000 pieces (1928 cartons)