FDA recall Z-0514-2022

Covidien, LP · Class II · device

Product

SonarMed AirWave Monitor Kit (Monitor, Sensor Cable, Power Cord), Item Code AW-M0001. used with endotracheal tube (ETT)

Reason for recall

Prior to use on a patient, the device alarm speaker failed to annunciate on power up and the device falsely detected a sensor cable disconnect and reconnect during setup. The monitor detection of a false sensor cable disconnect and reconnect may cause the monitor to discontinue monitoring and transition into the calibration screen without an audible alarm.

Distribution

The devices were distributed to the following US states: CA, CO, FL, IL, KY, MA, OH, TN, and TX.

Key facts

Status: Ongoing
Initiation date: 2021-12-22
Report date: 2022-01-26
Voluntary/Mandated: Voluntary: Firm initiated
Location: North Haven, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0514-2022