Health product recall

Cortrak*2 Enteral Access System (Eas)

Brand(s)
Avanos Medical, Inc.
Last updated

Summary

Product
Cortrak*2 Enteral Access System (Eas)
Issue
Medical devices - Labelling and packaging
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected Products

Lot or Serial Number

Model or catalog number

Cortrak*2 Enteral Access System (Eas)

All lots.

20-0950 (UDI 00350770472010), 20-0950 (UDI 10680651472011), P20-0950 (UDI 00350770472065), P20-0950 (UDI 10680651472066)

Issue

Avanos medical is conducting a voluntary field correction for the Cortrak* 2 Enteral Access System (Eas) because modifications to the labeling of the device have been initiated. Reports of injuries and patient deaths related to misplacement of nasogastric feeding tubes while operating the device per labeled instructions for use (IFU) and intended use have been received.

Recall start date: Mar 21, 2022

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
Companies

Avanos Medical, Inc.

5405 Windward Parkway, Alpharetta, Georgia, United States

30004-3894

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type I
Identification number
RA-64092

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