BEUDAMED
    FDA Enforcement Class III Terminated

    Medivance ArcticGel Neonatal Pad The pad is designed to fit into an incubator and provide whole body cooling for patients.

    Recall: Z-2345-2016 · Reported August 17, 2016

    Enforcement

    Recall Number
    Z-2345-2016
    Event ID
    74609
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    C.R. Bard, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 17, 2016
    Initiation Date
    June 30, 2016
    Classification Date
    August 5, 2016
    Termination Date
    June 6, 2017
    Address
    8195 Industrial Blvd NE, Covington, GA, 30014-1497, United States

    Description

    Medivance ArcticGel Neonatal Pad The pad is designed to fit into an incubator and provide whole body cooling for patients.

    Reason

    An internal review of an available product found that the Information For Use only contained English and Japanese languages when a CE-marked 23 language version was expected.

    Code Info

    Lot Numbers NGAN1721, NGAN1765, NGAP1807, NGAP2009, NGZK5402, NGZKY606, NGZKY607, NGZL3822

    Distribution

    US Distribution to the states of : CA, FL, GA, IL, IN, MI, MN, MO, NY, OR, PA, TX, WA, and Internationally to Germany, Italy and Switzerland

    Quantity

    64