FDA recall Z-0509-2020

Applied Medical Resources Corp · Class II · device

Product

Epix Electrosurgical Probes with Smoke Evacuation, Angled L-Hook Tip, 5mm x 42 cm REF CW002 QTY: 1 - Product Usage: The Epix Electrosurgical Probe with Smoke Evacuation is intended to deliver energy from an independent monopolar electrosurgical generator to cut and coagulate tissue during laparoscopic surgical procedures where the device is introduced into the body through a cannula. The device may be used for the evacuation of smoke created by electrosurgery at the surgical site.

Reason for recall

Unintentional shifting of the tip insulation of the firm's electrosurgical probes.

Distribution

Worldwide distribution - US Nationwide distribution and countries of Belgium; Germany; Switzerland; Spain; Finland; France; Great Britain; Israel; India; Italy; Lebanon; Netherlands; and Portugal.

Key facts

Status
Terminated
Initiation date
2018-12-12
Report date
2019-11-27
Termination date
2021-01-22
Voluntary/Mandated
Voluntary: Firm initiated
Location
Rancho Santa Margarita, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0509-2020