FDA-Device2024-11-20Class II
Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Rocker-Switch, Bulk Non-Sterile - 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. Catalog Number: 0703-047-002
Stryker Corporation
Hazard
There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentional activation of the device may result in localized burns to the patient or physician from electrical currents carried through conductive objects or fluids. Medical/surgical intervention may be needed to correct these injuries
Sold states
Worldwide distribution - US Nationwide and the countries of Canada, Japan, Australia.
Affected count
295,760 eaches
Manufactured in
1941 Stryker Way, N/A, Portage, MI, United States
Products
Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Rocker-Switch, Bulk Non-Sterile - 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. Catalog Number: 0703-047-002
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0366-2025Don't want to check this manually?
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