Medical device recalls Moderate risk

Stryker Instruments Div. of Stryker Corporation recalls Neptune E-SEP 165mm Blade Electrode, Catalog Number 0703-165-001 - Product Usage: The Neptune E-SEP is an Integrated Sm…

Recall date
March 26, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1807-2020
FDA classification
Class II
Brand / firm
Stryker Instruments Div. of Stryker Corporation
Sold / distributed
International distribution the country of Canada.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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