The Recall Desk
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.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. 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
  • placement-verification-failure

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.

Related recalls

Same category