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Cortrak 2 enteral access system

Official notice

7 Jun 2022

Last checked

7 Jun 2022

Medium riskHealth Canada

An official Health Canada notice concerns Cortrak 2 enteral access system. 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 Published 2022-06-07.

What to do now

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

Recall number

64243

Official notice

2022-06-07

The hazard

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

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

64243

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Affected products

Product 1

Affected products - Cortrak 2 Enteral Access System, Lot or serial number - All lots., Model or catalog number - P20-0950 20-0950

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Avanos Medical, Cortrak 2 Enteral Access System.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

64243

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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