Device product
Product/Part: YelloPort Elite 12x75 Pencil Point Trocar/ET1207503; YelloPort Elite Hasson Adaptor 10mm/EA10NH. For use in laparoscopic procedures.
Z-1852-2022
Product summary
- Event
- Event 90801
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 19
- Official record key
device-enforcement:Z-1852-2022
Official wording
Reason: Laparoscopic devices have a sterile symbol included on labels but devices are non-sterile.
Code information: Part/UDI-DI/Lot: ET1207503/05051986012438/735479, EA10NH/05051986012100/734029
Distribution pattern: US: MA
Derived failure modes
-
Unknown
Laparoscopic devices have a sterile symbol included on labels but devices are non-sterile.