Recall Z-1032-2022 ยท KNT Tubes, Gastrointestinal (And Accessories)
Avanos Medical, Inc.
Avanos Cortrak 2 Enteral Access System (EAS)
| Date | May 13, 2022 (initiated Mar 21, 2022) |
| Status | Terminated |
| 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. |
| 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 avanos-fca002@iqvia.com, Phone Number (855) 365-3981. STOP using the Anonymous Account Mode feature o |
| Quantity | 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. |
| FDA record | Open on fda.gov |