BEUDAMED
    FDA Recall 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 · Initiated June 30, 2016

    Recall

    Recall Number
    Z-2345-2016
    Event Number
    74609
    Firm
    C.R. Bard, Inc.
    FEI Number
    1018233
    Product Code
    DWJ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 30, 2016
    Posted
    August 5, 2016
    Terminated
    June 6, 2017
    Address
    8195 Industrial Blvd NE, Covington, GA, 30014-1497

    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.

    Action

    A Customer Communication Correction Letter was sent to customers on June 30, 2016. The letter requested that they examine inventory and remove the original IFU and substitute a copy of the IFU that was included with the Correction letter. The letter also requested a sub-recall, and included a reply form which was to be completed and returned. If you have any further questions please call (401) 825-8690.

    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