FDA recall Z-0251-2020
Senseonics, Inc. · Class II · device
Product
Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor
Reason for recall
Eversense Sensors have prematurely stopped functioning due to inadequate hydration of the sensor s glucose-sensing surface
Distribution
Nationwide
Key facts
- Status
- Terminated
- Initiation date
- 2019-09-18
- Report date
- 2019-11-06
- Termination date
- 2020-07-30
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Germantown, MD, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0251-2020