FDA-Device2020-11-11Class II

A Li-Gator Single Use Laparoscopic Clip Applier, 10 mm X 29 cm - Product Usage: intended for use on tubular structures or vessel wherever a metal litigating clip is intended

Genicon, Inc.
Hazard

Device malfunction causing the applier to jam, and clip loading failures.

Sold states
Worldwide distribution - US Nationwide distribution including in the states of FL, TN, MO, CA, GA, and IN. The countries of Chile, Croatia, Dubai (UAE), Equador, Egypt, France, Germany, Greece, Guatemala, Hong Kong, Iraq, Ireland, Israel, Jordan, Kuwait, Lebanon, Malta, Mexico, Morocco, Pakistan, Palestinian, Quatar, Saudi Arabia, Slovenia, South Africa, Switzerland, Tunisia, United Kingdom, and Venezuela.
Affected count
8,872 devices
Manufactured in
6869 Stapoint Ct Ste 112, N/A, Winter Park, FL, United States
Products
A Li-Gator Single Use Laparoscopic Clip Applier, 10 mm X 29 cm - Product Usage: intended for use on tubular structures or vessel wherever a metal litigating clip is intended

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0310-2021

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