Device Recall Bard ArcticGel Pads

  • Model / Serial
    All lots with Catalog numbers: 31700 (Universal Pad), 3170004 (Universal Pad 4 pk), 31703 (XSmall pad kit), 3170302 (XSmall pad kit 2 pk), 31705 (Small pad kit), 3170502 (Small pad kit 2 pk), 31707 (Medium pad kit), 3170702 (Medium pad kit 2 pk), 31709 (Large pad kit) and 3170902 (Large pad kit 2 pk), that are within their current expiration dates.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product 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.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    C.R. Bard, Inc., 8195 Industrial Blvd NE, Covington GA 30014-1497
  • Manufacturer Parent Company (2017)
  • Source
    USFDA