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Recall Observatory FDA recall evidence

Device product

Product/Part: YelloPort Plus 5x70 Cannula + Luer/YC0507001. For use in laparoscopic procedures.

Z-1853-2022

January 20, 2022

Class II

Product summary

Firm
Surgical Innovations Ltd
Event
Event 90801
Status
Ongoing
Classification
Class II
Quantity
1
Official record key
device-enforcement:Z-1853-2022

Official wording

Reason: Laparoscopic devices have a sterile symbol included on labels but devices are non-sterile.

Code information: Part/UDI-DI/Lot: YC0507001/05051986001890/735652

Distribution pattern: US: MA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Laparoscopic devices have a sterile symbol included on labels but devices are non-sterile.