Device product
Covidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM REF: 90042
Z-2271-2026
Product summary
- Firm
- Covidien LLC
- Event
- Event 98859
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 23,000 units
- Official record key
device-enforcement:Z-2271-2026
Official wording
Reason: Temperature probe devices lack FDA clearance.
Code information: UDI: 30884521820900/ Lot: 25D1267JZX 25E1322JZX, 25E1324JZX, 25H0920JZX,
Distribution pattern: US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, FL, GA, HI, IL, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, PR, TN, TX, UT, VA, WA, WV.
Derived failure modes
-
Unknown
Temperature probe devices lack FDA clearance.