Cortrak 2 Enteral Access System
Brand(s)
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 |
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:
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
Healthcare
Recall class
Type II
Identification number
RA-64243
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