BEUDAMED
    FDA Enforcement Class II Terminated

    Lifeguard Infusion Set with Smartsite, 20Ga, 1, CLGY-2010 Huber type needle set used for the infusion of medical fluids into implantable ports.

    Recall: Z-0914-2013 · Reported March 13, 2013

    Enforcement

    Recall Number
    Z-0914-2013
    Event ID
    64464
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Churchill Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 13, 2013
    Initiation Date
    January 21, 2013
    Classification Date
    March 6, 2013
    Termination Date
    September 10, 2013
    Address
    87 Venture Drive, N/A, Dover, NH, 03820-5914, United States

    Description

    Lifeguard Infusion Set with Smartsite, 20Ga, 1, CLGY-2010 Huber type needle set used for the infusion of medical fluids into implantable ports.

    Reason

    The label on the device states that the item number is CLGY-2210 when the item number on the device label should read CLGY-2010. This is a 20Ga Huber needle set; however, the product label states the pouch contains a 22Ga set.

    Code Info

    Lot #1210099

    Distribution

    Nationwide Distribution including MO, IL, FL, PA, VA, MO, NY, NE, NH, and OH.

    Quantity

    2340