Z-1032-2022 Class I Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 25, 2022
- Initiation Date
- March 21, 2022
- Termination Date
- September 9, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 721 devices
Product Description
Avanos Cortrak 2 Enteral Access System (EAS)
Reason for Recall
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.
Distribution Pattern
Worldwide Distribution. US Nationwide, Australia, Austria, Canada, Germany, Ireland, Kuwait, New Zealand, India, Japan, Malaysia, Netherlands, Panama, Singapore, Switzerland, and United Kingdom.
Code Information
1) Product Code 20-0950, CORTRAK 2 Enteral Access System (EAS), UDI: 00350770472010; all serial numbers 2) Product Code P20-0950, CORTRAK 2 Enteral Access System (EAS) - Loaner Unit, UDI: 00350770472065; all serial numbers 3) Product Code 20-0950, CORTRAK 2 Enteral Access System (EAS) - Halyard version; UDI: 10680651472011; all serial numbers 4) Product Code P20-0950, CORTRAK 2 Enteral Access System (EAS) - Loaner Unit - Halyard version; UDI: 10680651472066; all serial numbers