BEUDAMED
    FDA Recall Terminated

    Premier Value Lancing Device. UPC Code: 840986016707, The Package Includes: 1 Lancing Device, 1 Clear Cap and 5 Premier Value Ultra Thin Lancets, Distributed by: Chain Drug Consortium, LLC, Boca Raton, FL 33431. Lancing Device intended to be used by diabetes patients that require a drop of capillary blood for testing.

    Recall: Z-0174-2009 · Initiated July 18, 2008

    Recall

    Recall Number
    Z-0174-2009
    Event Number
    49360
    Firm
    Facet Technologies
    FEI Number
    3011617315
    Product Code
    FMK
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    July 18, 2008
    Posted
    October 27, 2008
    Terminated
    August 24, 2009
    Address
    101 Liberty Industrial Pkwy, McDonough, GA, 30253-7556

    Description

    Premier Value Lancing Device. UPC Code: 840986016707, The Package Includes: 1 Lancing Device, 1 Clear Cap and 5 Premier Value Ultra Thin Lancets, Distributed by: Chain Drug Consortium, LLC, Boca Raton, FL 33431. Lancing Device intended to be used by diabetes patients that require a drop of capillary blood for testing.

    Reason

    The Alternate Site Cap was not included in the package as indicated on the labeling.

    Action

    The consignees were notified by letter on/about 7/18/2008. The Return Material Authorization number was communicated to the customer. They were asked to place the items on hold and Can Am will obtain any quantities. The Returned Product Mechanics Process will: Inventory will be sent back to Facet in two stages, Inventory on hand at Cimetra will be sent back to Facet, Inventory received back from customers will be sent back to Facet in one shipment 30-60 days after notice. Inventory received back after this second shipment will be destroyed.

    Distribution

    Nationwide--GA and FL.

    Quantity

    2976 units