🔍 RecallPedia

Avanos Cortrak 2 Enteral Access System (EAS)

Class I - Dangerous
🏥 Medical Devices Recalled: March 21, 2022 Avanos Medical Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Avanos Cortrak 2 Enteral Access System (EAS)

Product Codes/Lot 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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1032-2022

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