Summary
The FDA issued a Class I for Avanos Cortrak 2 Enteral Access System (EAS) by Avanos Medical, Inc.. Reason: Product labeling is being modified. STOP using the Anonymous Account Mode feature of the CORTRAK 2 device immediately. CONFIRM placement of the NG/NI.
Details
Source
Device Recall
External ID
Z-1032-2022
Action Date
2022-05-25
Status
Terminated
Category
device
Product Description
Avanos Cortrak 2 Enteral Access System (EAS)
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
Quantity Affected: 721 devices
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-03-21
Company
Alpharetta, GA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 164 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Avanos Medical, Inc. has 55 FDA actions in our database, including 51 recalls and 4 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Avanos Medical, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Avanos Medical, Inc. have FDA actions?
Avanos Medical, Inc. has 55 FDA actions in our database, including 51 recalls and 4 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1032-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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