Reported Jan 26, 2022 · Ongoing
SonarMed AirWave Monitor Kit (Monitor, Sensor Cable, Power Cord), Item Code AW-M0001. used with endotracheal tube (ETT)
Covidien, LP
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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: Covidien, LP · 60 Middletown Ave · North Haven, CT · 06473-3908
Is this the product you have?
- SonarMed AirWave Monitor Kit (Monitor, Sensor Cable, Power Cord), Item Code AW-M0001. used with endotracheal tube (ETT)
- Lot codes and dates
- UDI-Device Identifier (GTIN/UPN)00851334007001
- Serial Numbers
66 of 66 codes
AW0501AW0519AW0537AW0556AW0502AW0520AW0540AW0557AW0503AW0521AW0541AW0558AW0504AW0522AW0542AW0559AW0505AW0524AW0543AW0560AW0506AW0525AW0544AW0561AW0507AW0526AW0545AW0562AW0508AW0527AW0546AW0563AW0509AW0528AW0548AW0564AW0510AW0529AW0549AW0565AW0511AW0530AW0550AW0566AW0512AW0531AW0551AW0567AW0513AW0532AW0552AW0568AW0514AW0533AW0553AW0569AW0515AW0536AW0554AW0570
- Amount recalled
- 66 devices
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Covidien, LP recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.