Device product
YelloPort Elite, REF: EO0509505, 5x95 Optical Trocar, Rx Only, SterileR
Z-1602-2023
Product summary
- Event
- Event 92114
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3405 units
- Official record key
device-enforcement:Z-1602-2023
Official wording
Reason: Optical Trocars sterility assurance can not be guaranteed
Code information: Lot # 738182 ; UDI-DI: (01) 05051986013428
Distribution pattern: US: MA OUS: None
Derived failure modes
-
Sterility assurance
sterility assurance can not be guaranteed