Avanos Cortrak 2 Enteral Access System (EAS)
This recall has been terminated (originally issued May 13, 2022).
- Company
- Avanos Medical, Inc.
- Recall Initiated
- March 21, 2022
- Posted
- May 13, 2022
- Terminated
- September 9, 2024
- Recall Number
- Z-1032-2022
- Quantity
- 721 devices
- Firm Location
- Alpharetta, GA
- Official Source
- View on FDA website ↗
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
Worldwide Distribution. US Nationwide, Australia, Austria, Canada, Germany, Ireland, Kuwait, New Zealand, India, Japan, Malaysia, Netherlands, Panama, Singapore, Switzerland, and United Kingdom.
Lot / Code Info
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
Root Cause
Device Design
Action Taken
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.