Health product recall

Cortrak 2 Enteral Access System

Last updated

Summary

Product
Cortrak 2 Enteral Access System
Issue
Medical devices - Unauthorised device
What to do

Discontinue use of these products until the licence issues has been resolved. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

Cortrak 2 Enteral Access System

All lots.

P20-0950
20-0950

Issue

The recall is being conducted due to information received from Health Canada, that the device which was classified by Avanos Medical as a class 1 medical device, should be reclassified in a higher medical device class. Higher class devices require a Health Canada license application and approval.

Recall start date: May 26, 2022

Additional information

Details
Original published date: 2022-06-10
Alert / recall type
Health product recall
Category
Health product - Medical device - General hospital and personal use
Companies

Avanos Medical, Inc. 

5405 Windward Parkway, Alpharetta, Georgia, United States, 30004-3894

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-64243