Covidien, LP 2022-01-26 Health serious FDA
Health · FDA · Recall #FDA-Z-0514-2022
SonarMed AirWave Monitor Kit (Monitor, Sensor Cable, Power Cord), Item Code AW-M0001. … Recall
Issued January 26, 2022 · Covidien, LP
In January 2022, Covidien, LP recalled the SonarMed AirWave Monitor Kit (Monitor, Sensor Cable, Power Cord), Item Code AW-M0001. …, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using SonarMed AirWave Monitor Kit (Monitor, Sensor Cable, Power Cord), Item Code AW-M0001. … right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Covidien, LP to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Covidien, LP
- Category
- Health
- Recall date
- January 26, 2022
- Units affected
- Not reported
- Sold at
- The devices were distributed to the following US states: CA, CO, FL, IL, KY, MA, OH, TN, and TX.
- Recall number
- FDA-Z-0514-2022
- Made in
- United States
- Issuing agency
- FDA
In context
- Covidien, LP has 5 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.