PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: November 11, 2020 Initiated: September 17, 2020 #Z-0310-2021

Product Description

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

Reason for Recall

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

Details

Recalling Firm
Genicon, Inc.
Units Affected
8,872 devices
Distribution
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.
Location
Winter Park, FL

Frequently Asked Questions

What product 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. Recalled by Genicon, Inc.. Units affected: 8,872 devices.
Why was this product recalled?
Device malfunction causing the applier to jam, and clip loading failures.
Which agency issued this recall?
This recall was issued by the FDA Devices on November 11, 2020. Severity: Moderate. Recall number: Z-0310-2021.