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Recall Observatory FDA recall evidence

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.

Z-1807-2020

March 26, 2020

Class II

Product summary

Firm
Stryker Instruments Div. of Stryker Corporation
Event
Event 85402
Status
Terminated
Classification
Class II
Quantity
40 units
Official record key
device-enforcement:Z-1807-2020

Official wording

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

Code information: Lot 16240231, GTIN 07613327297799

Distribution pattern: International distribution the country of Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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