FDA-Device2016-04-20Class II
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.
C.R. Bard, Inc.
Hazard
Complaints were received of restricted/inaccurate flow rate.
Sold states
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.
Affected count
21,412 units
Manufactured in
8195 Industrial Blvd NE, N/A, Covington, GA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1395-2016Don't want to check this manually?
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