Z-1032-2022 Class I Terminated
FDA device recall Z-1032-2022 was initiated by Avanos Medical, Inc. on Mar 21, 2022 and is designated Class I. 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. The recall status is terminated (terminated Sep 9, 2024). Affected quantity: 721 devices.
Recall Details
- Product Type
- Devices
- Report Date
- May 25, 2022
- Initiation Date
- Mar 21, 2022
- Termination Date
- Sep 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1032-2022
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026