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Cortrak*2 enteral access system (eas)

Official notice

19 Apr 2022

Last checked

19 Apr 2022

High riskHealth Canada

An official Health Canada notice concerns Cortrak*2 enteral access system (eas). 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 Published 2022-04-19.

What to do now

Contact the manufacturer if you require additional information.

Recall number

64092

Official notice

2022-04-19

The hazard

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

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

64092

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Affected products

Product 1

Affected Products - Cortrak*2 Enteral Access System (Eas), Lot or Serial Number - All lots., Model or catalog number - 20-0950 (UDI 00350770472010), 20-0950 (UDI 10680651472011), P20-0950 (UDI 00350770472065), P20-0950 (UDI 10680651472066)

Risk / hazard

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

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 I

App estimate

high

Recall details

Recall number

64092

Classification

Type I

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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