Z-1032-2022Class I

Avanos Cortrak 2 Enteral Access System (EAS)

Name: Z-1032-2022 Avanos Cortrak 2 Enteral Access System (EAS)
Creator: Avanos Medical, Inc.
Published: 2022-03-21
License: https://open.fda.gov/license/

Halyard Health / initiated 2022-03-21 / Terminated / root cause: design

FDA source

Avanos Medical, Inc. began a recall of Avanos Cortrak 2 Enteral Access System (EAS) on 2022-03-21. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1032-2022
Classification: Class I
Status: Terminated
Initiated: 2022-03-21
Posted: 2022-05-13
Terminated: 2024-09-09
Recalling firm: Halyard Health
Product: Avanos Cortrak 2 Enteral Access System (EAS)
Product code: KNT Tubes, Gastrointestinal (And Accessories)
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.
Root cause tag: design
FDA root cause: Device Design
Action: 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 [email protected], 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.
Quantity in commerce: 721 devices
Distribution: Worldwide Distribution. US Nationwide, Australia, Austria, Canada, Germany, Ireland, Kuwait, New Zealand, India, Japan, Malaysia, Netherlands, Panama, Singapore, Switzerland, and United Kingdom.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1032-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1032-2022	Class I	Terminated	Voluntary: Firm initiated	2022-05-25	2022-05-13

Product code KNT

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)