FDA-Device2022-03-16Class II
NIM TRIVANTAGE EMG Endotracheal Tube
Medtronic Xomed, Inc.
Hazard
There is potential for multiple issues due to a manufacturing nonconformity.
Sold states
Worldwide distribution - US Nationwide and the countries of Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Faroe Islands, Finland, France, French Guinea, Germany, Greece, Guadeloupe, Guam, Guatemala, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Korea (Republic of), Kuwait, Lebanon, Libya, Luxembourg, Malaysia, Mauritius, Mayotte, Mexico, Morocco, Namibia, Netherlands, New Caledonia, New Zealand, North Macedonia, Norway, Panama, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom, and Vietnam.
Affected count
301,926 devices
Manufactured in
6743 Southpoint Dr N, N/A, Jacksonville, FL, United States
Products
NIM TRIVANTAGE EMG Endotracheal Tube
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0743-2022Don't want to check this manually?
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