Avanos Medical, Inc.: Avanos Cortrak 2 Enteral Access System (EAS)

Is my product affected?

Avanos Cortrak 2 Enteral Access System (EAS)

• UPC 00350770472010
• UPC 00350770472065
• UPC 10680651472011
• UPC 10680651472066

Check against the official notice below — it lists the full affected range.

What happened

Avanos Medical is recalling 721 Cortrak 2 Enteral Access System (EAS) devices distributed worldwide, including throughout the United States and multiple other countries. The recall affects all serial numbers of four product variants: the standard Cortrak 2 EAS, the Cortrak 2 EAS Loaner Unit, and both Halyard versions of these devices. The reason for the recall is that product labeling is being modified due to a safety concern with the Anonymous Account Mode feature.

Users of the Cortrak 2 EAS device should immediately stop using the Anonymous Account Mode feature and confirm placement of nasogastric or nasoenteric tubes according to their institution's protocol. The source document does not specify a remedy or further action required.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Product labeling is being modified. STOP using the Anonymous Account Mode feature of the CORTRAK 2 device immediately. CONFIRM placement of the NG/NI tube per institution protocol.

Details from the source

Reason for recall: Product labeling is being modified. STOP using the Anonymous Account Mode feature of the CORTRAK 2 device immediately. CONFIRM placement of the NG/NI tube per institution protocol. Distribution: Worldwide Distribution. US Nationwide, Australia, Austria, Canada, Germany, Ireland, Kuwait, New Zealand, India, Japan, Malaysia, Netherlands, Panama, Singapore, Switzerland, and United Kingdom. Quantity: 721 devices Lot/code info: 1) Product Code 20-0950, CORTRAK 2 Enteral Access System (EAS), UDI: 00350770472010; all serial numbers 2) Product Code P20-0950, CORTRAK 2 Enteral Access System (EAS) - Loaner Unit, UDI: 00350770472065; all serial numbers 3) Product Code 20-0950, CORTRAK 2 Enteral Access System (EAS) - Halyard version; UDI: 10680651472011; all serial numbers 4) Product Code P20-0950, CORTRAK 2 Enteral Access System (EAS) - Loaner Unit - Halyard version; UDI: 10680651472066; all serial numbers

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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