BEUDAMED
    FDA Recall Open, Classified

    Arctic Sun ArcticGel Pads - Medium, Product Code 317-07

    Recall: Z-0590-2018 · Initiated June 2, 2017

    Recall

    Recall Number
    Z-0590-2018
    Event Number
    77469
    Firm
    C.R. Bard, Inc.
    FEI Number
    1018233
    Product Code
    DWJ
    Status
    Open, Classified
    Root Cause
    Labeling mix-ups
    Initiated
    June 2, 2017
    Address
    8195 Industrial Blvd NE, Covington, GA, 30014-1497

    Description

    Arctic Sun ArcticGel Pads - Medium, Product Code 317-07

    Reason

    Label on product box contains the incorrect reference #317-09 while the shelf box label with barcode and the internal foil pouch label are correctly labeled with product code 317-07 and lot number NDAR0462.

    Action

    Customers were notified on approximately 06/02/2017 via FedEx with delivery confirmation and per the individual country's delivery system. Instructions included to examine inventory and identify any product subject to the recall and notify customers if product was further distributed. If customers wished to return product, they were instructed to contact customer service at 1-800-526-4455.

    Distribution

    Distributed domestically. Distributed internationally to Australia and Belgium.

    Quantity

    128 units