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.
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