FDA recall Z-0743-2022

Product

NIM TRIVANTAGE EMG Endotracheal Tube

Reason for recall

There is potential for multiple issues due to a manufacturing nonconformity.

Distribution

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.

Key facts

Status

Ongoing

Initiation date

2021-12-22

Report date

2022-03-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Jacksonville, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0743-2022