Recall archive / FDA device enforcement
Avanos Cortrak 2 Enteral Access System (EAS) — FDA record Z-1032-2022
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Mar 21, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class I
- Recalling firm
- Avanos Medical, Inc.
- Quantity
- 721 devices
- Agency-reported status
- Terminated
- Source record identifier
- Z-1032-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide Distribution. US Nationwide, Australia, Austria, Canada, Germany, Ireland, Kuwait, New Zealand, India, Japan, Malaysia, Netherlands, Panama, Singapore, Switzerland, and United Kingdom.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- May 25, 2022
- Recall initiation date
- Mar 21, 2022
- Center classification date
- May 13, 2022
- Termination date
- Sep 9, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.