The Recall Desk
Agency classClass IOur severity:CriticalFDA (Devices)·Z-1032-2022·Announced 2022-05-25

Avanos Cortrak 2 Enteral Access System Anonymous Account Mode Discontinued

Avanos Medical is modifying labeling for the Cortrak 2 Enteral Access System and discontinuing the Anonymous Account Mode feature. Users must confirm tube placement per institutional protocol.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The FDA classified this device recall as Class I, which is reserved for defects where there is reasonable probability that use of the product will cause serious adverse health consequences or death. The defect affects verification of proper tube placement, a critical patient safety function.

Plain-English summary

The Cortrak 2 Enteral Access System, manufactured by Avanos Medical, is subject to labeling modifications. The Anonymous Account Mode feature of the device must be discontinued immediately.

Approximately 721 devices are affected by this recall. Affected devices are distributed worldwide, including throughout the United States, Australia, Austria, Canada, Germany, Ireland, Kuwait, New Zealand, India, Japan, Malaysia, Netherlands, Panama, Singapore, Switzerland, and the United Kingdom.

Users must immediately cease using the Anonymous Account Mode feature of the Cortrak 2 system. Placement of nasogastric or nasointestinal tubes must be confirmed according to each institution's established protocol.

Healthcare facilities should update their procedures and staff training to ensure all users do not use the Anonymous Account Mode feature and properly confirm tube placement per their institution's established protocol.

The recalled product

Product
Avanos Cortrak 2 Enteral Access System (EAS)
Manufacturer
Avanos Medical, Inc.
Category
Medical Device — Enteral Access System
Hazard
Affected units
721

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (13)

  • 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

Distribution

Distributed nationwide across the United States.

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