FDAClass IINovember 11, 2020

A Li-Gator Single Use Laparoscopic Clip Applier recall

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…

Why was A Li-Gator Single Use Laparoscopic Clip Applier recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model # 360-010-001 (A Li-Gator) lot codes: I8250 I8251 I8252 I8820 I8821 I8822 I8823 I8824 I8825 I9571-A I9572-A I9573-A I9716-A I9717-A I9718-A I9719-A J0113-A J0114-A J0115-A J0225-A J0227-A J0228-A J0229-A J0230-A J0231-A J0240-A J0243-A J0287-A

Product
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…
Recalling firm
Genicon, Inc.
Quantity
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.
Recall date
November 11, 2020
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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