FDA-Device2022-05-25Class I
Avanos Cortrak 2 Enteral Access System (EAS)
Avanos Medical, Inc.
Hazard
Product labeling is being modified. STOP using the Anonymous Account Mode feature of the CORTRAK 2 device immediately. CONFIRM placement of the NG/NI tube per institution protocol.
Sold states
Worldwide Distribution. US Nationwide, Australia, Austria, Canada, Germany, Ireland, Kuwait, New Zealand, India, Japan, Malaysia, Netherlands, Panama, Singapore, Switzerland, and United Kingdom.
Affected count
721 devices
Manufactured in
5405 Windward Pkwy, N/A, Alpharetta, GA, United States
Products
Avanos Cortrak 2 Enteral Access System (EAS)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1032-2022Don't want to check this manually?
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