Avanos Medical, Inc. Avanos Cortrak 2 Enteral Access System (EAS) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Avanos Cortrak 2 Enteral Access System (EAS)
Brand
Avanos Medical, Inc.
Lot Codes / Batch Numbers
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
Products Sold
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
Avanos Medical, Inc. is recalling Avanos Cortrak 2 Enteral Access System (EAS) due to Product labeling is being modified. STOP using the Anonymous Account Mode feature of the CORTRAK 2 device immediately. CONFIRM placement of the NG/NI. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Avanos Medical issued URGENT: FIELD CORRECTION Notices dated March 18 and March 21, 2022. Phase 2 of the field action will occur later. The Notices instructed consignees to: CHECK all storage and usage locations to determine if any impacted product remains within your possession. ATTACH THIS LETTER to the Operators Manual until a revised Operators Manual, Quick Start Guide and Troubleshooting Tip Cards are available. COMPLETE and RETURN the Acknowledgement Form to Avanos, via email to avanos-fca002@iqvia.com, Phone Number (855) 365-3981. STOP using the Anonymous Account Mode feature of the CORTRAK 2 device immediately. CONFIRM placement of the NG/NI tube per institution protocol. USE extreme caution in patients who are combative or who move excessively during placement as the receiver unit may move, impacting the placement tracing. If a deviation from the midline is seen on the All-In-One Monitor display during advancement in the upper quadrants, or resistance is encountered: 1) STOP advancement of the system. 2) REMOVE the tube and stylet and assess the patient for injury per institutional protocol Device should only be used by qualified, trained users. If you need additional training, please contact your local field sales representative. Phase 2 letters were sent via FedEx to all consignees on 09/27/2022 and included physical copies of the updated versions of the Operator's Manual, Quick Reference Guide, and Troubleshooting Tips.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026