Reported May 25, 2022 · Terminated
Avanos Cortrak 2 Enteral Access System (EAS)
Avanos Medical, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Avanos Medical, Inc. · 5405 Windward Pkwy · Alpharetta, GA · 30004-3894
Is this the product you have?
- Avanos Cortrak 2 Enteral Access System (EAS)
- Lot codes and dates
4 of 4 products
Products covered by this recall Model / number Barcodes Product as published 20-095000350770472010CORTRAK 2 Enteral Access System (EAS), UDI: 00350770472010; all serial numbers P20-095000350770472065CORTRAK 2 Enteral Access System (EAS) - Loaner Unit, UDI: 00350770472065; all serial numbers 20-095010680651472011CORTRAK 2 Enteral Access System (EAS) - Halyard version; UDI: 10680651472011; all serial numbers P20-095010680651472066CORTRAK 2 Enteral Access System (EAS) - Loaner Unit - Halyard version; UDI: 10680651472066; all serial numbers - Amount recalled
- 721 devices
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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