FDA-Device2020-05-06Class II

Neptune E-SEP 165mm Blade Electrode, Catalog Number 0703-165-001 - Product Usage: The Neptune E-SEP is an Integrated Smoke Evacuation Pencil (pencil) designed for general electrosurgical applications including cutting and coagulation, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.

Stryker Instruments Div. of Stryker Corporation
Hazard

Due to a distribution error, product from the affected lot was shipped expired.

Sold states
International distribution the country of Canada.
Affected count
40 units
Manufactured in
4100 E Milham Ave, N/A, Portage, MI, United States
Products
Neptune E-SEP 165mm Blade Electrode, Catalog Number 0703-165-001 - Product Usage: The Neptune E-SEP is an Integrated Smoke Evacuation Pencil (pencil) designed for general electrosurgical applications including cutting and coagulation, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1807-2020

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