BEUDAMED
    FDA Recall Terminated

    BARD ArcticGel Pads Product Usage: The Arctic Sun Temperature Management System is intended for monitoring and controlling patient temperature. ArcticGel Pads are only for use with an Arctic Sun Temperature Management System Control Module.

    Recall: Z-1395-2016 · Initiated March 4, 2016

    Recall

    Recall Number
    Z-1395-2016
    Event Number
    73454
    Firm
    C.R. Bard, Inc.
    FEI Number
    1018233
    Product Code
    DWJ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    March 4, 2016
    Terminated
    December 7, 2017
    Address
    8195 Industrial Blvd NE, Covington, GA, 30014-1497

    Description

    BARD ArcticGel Pads Product Usage: The Arctic Sun Temperature Management System is intended for monitoring and controlling patient temperature. ArcticGel Pads are only for use with an Arctic Sun Temperature Management System Control Module.

    Reason

    Complaints were received of restricted/inaccurate flow rate.

    Action

    Bard Medical sent an Urgent Medical Product Recall letter dated March 4, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to not use any of the affected products and to return any unused product Bard Medical Division via the provided Customer Recall and Effectiveness Form. BMD will be providing a replacement for the returned product. If the product was further distributed, the consignee was instructed to identify their customers and notify them of the product recall.

    Distribution

    Worldwide Distribution - Domestic: US Nationwide; Foreign: Argentina, Australia, Austria, Belarus, Belgium, Bosnia, Brazil Canada, Chile, China, Colombia, Croatia, Cyprus, Denmark, Egypt, Finland, France, Germany, Greece, Oman Kong, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, , South Korea, Kuwait, Macedonia, Malaysia, Mexico, New Zealand, Norway, Oman, Pakistan, Paraguay, Peru, Philippines, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, The Netherlands, Turkey, United Arab Emirates, Ukraine, United Kingdom, Uruguay and Vietnam.

    Quantity

    21,412 units