FDA Device recall Z-1032-2022
Avanos Cortrak 2 Enteral Access System (EAS)
- FDA Device
- Class I
- terminated
- Published 2022-05-25
On 2022-05-25 the FDA classified a Class I recall of Avanos Cortrak 2 Enteral Access System (EAS) by Avanos Medical, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1032-2022 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2022-03-21 |
| Published | 2022-05-25 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Avanos Medical |
| Distribution | US |
Product
Avanos Cortrak 2 Enteral Access System (EAS)
Reason
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.
Identifiers
| code_info | 1) Product Code 20-0950, CORTRAK 2 Enteral Access System (EAS), UDI: 00350770472010; all serial numbers 2) Product Cod…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1032-2022%22
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