BEUDAMED
    FDA Enforcement Class II Terminated

    NovaPlus Brand Warm Gel Infant Heel Gel Warmer, Item # V6391 NovaPlus Brand Liquid Heal Warmer. Item #V6393 Single Use and Disposable To provide gentle heat to increase blood flow and enhance infant blood sample collection

    Recall: Z-1301-2015 · Reported March 25, 2015

    Enforcement

    Recall Number
    Z-1301-2015
    Event ID
    70286
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    CooperSurgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    March 25, 2015
    Initiation Date
    January 26, 2015
    Classification Date
    March 19, 2015
    Termination Date
    June 14, 2016
    Address
    75 Corporate Dr, Trumbull, CT, 06611-1350, United States

    Description

    NovaPlus Brand Warm Gel Infant Heel Gel Warmer, Item # V6391 NovaPlus Brand Liquid Heal Warmer. Item #V6393 Single Use and Disposable To provide gentle heat to increase blood flow and enhance infant blood sample collection

    Reason

    Products without expiration date have the remote potential for minor burn

    Code Info

    Products without an expiration date and lot number

    Distribution

    Worldwide Distribution - USA (nationwide) and Internationally to AUSTRALIA, BAHRAIN, BERMUDA, CANADA, FRANCE, LATVIA, LIBYA, MEXICO, NEW ZEALAND, QATAR, SAUDI ARABIA, SINGAPORE, and UNITED KINGDOM.

    Quantity

    4938266 units