FDA recall Z-1032-2022

Product

Avanos Cortrak 2 Enteral Access System (EAS)

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.

Key facts

Status

Terminated

Initiation date

2022-03-21

Report date

2022-05-25

Termination date

2024-09-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Alpharetta, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1032-2022