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Avanos Cortrak 2 Enteral Access System (EAS) recallZ-1032-2022 · Avanos Medical, Inc. · initiated Mar 21, 2022

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Avanos Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Device Design

What the company is doing

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.

Recall details

Recall number
Z-1032-2022
Status
Terminated
Initiated by the company
Mar 21, 2022
Posted by the FDA
May 13, 2022
Recalling firm
Avanos Medical, Inc.
Quantity
721 devices
Product code
KNT
FDA submissions
K191340, K113351
Distribution
Worldwide Distribution. US Nationwide, Australia, Austria, Canada, Germany, Ireland, Kuwait, New Zealand, India, Japan, Malaysia, Netherlands, Panama, Singapore, Switzerland, and United Kingdom.

Product description

Avanos Cortrak 2 Enteral Access System (EAS)

Code information (models, lots, serial 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

Devices named in this recall

4 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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