Avanos Cortrak 2 Enteral Access System (EAS)
FDA device recall Z-1032-2022 · posted 2022-05-13 · Terminated
Recall details
- Recalling firm
- Avanos Medical, Inc.
- 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.
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- KNT
- Quantity affected
- 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.
- Date initiated
- 2022-03-21
- Date posted
- 2022-05-13
- Date terminated
- 2024-09-09
- Location
- Alpharetta, GA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CORTRAK* 2 Equilateral Enteral Access System (K191340) | Avanos Medical, Inc. | 2019-06-04 |
| CORTRAK ENTERAL ACCESS DEVICE (K113351) | Corpak Medsystems | 2012-01-10 |