Genicon, Inc. recalls A Li-Gator Single Use Laparoscopic Clip Applier, 10 mm X 29 cm - Product Usage: intended for use on tubular structures…

Recall date

September 17, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0310-2021

FDA classification

Class II

Brand / firm

Genicon, Inc.

Sold / distributed

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, P…

Why it was recalled

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

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

What was recalled

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