FDA recall Z-1807-2020

Stryker Instruments Div. of Stryker Corporation · Class II · device

Product

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.

Reason for recall

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

Distribution

International distribution the country of Canada.

Key facts

Status: Terminated
Initiation date: 2020-03-26
Report date: 2020-05-06
Termination date: 2020-07-15
Voluntary/Mandated: Voluntary: Firm initiated
Location: Portage, MI, United States

Primary source

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