Device product
Medtronic, Simplera Sensor, REF: MMT-5100JD1
Z-0033-2026
Product summary
- Event
- Event 96745
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,440 units
- Official record key
device-enforcement:Z-0033-2026
Official wording
Reason: The device cap label may not adhere to the sensor, compromising the sterility of the sensor, and increasing the risk of infection.
Code information: Lot # HG81GLZ/ GTIN: 20763000649580
Distribution pattern: US: No distribution OUS: Austria, Belgium, Italy, Spain, Switzerland, United Kingdom
Derived failure modes
-
Unknown
The device cap label may not adhere to the sensor, compromising the sterility of the sensor, and increasing the risk of infection.