Recall Z-0310-2021— Genicon, Inc.

Name: FDA recall Z-0310-2021
Creator: U.S. Food and Drug Administration
Published: 2020-09-17

Class II · Ongoing

Class II FDA medical device recall by Genicon, Inc., initiated 2020-09-17. It names one FDA 510(k) clearance: K030269. 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 litigating clip is intended. Reason: Device malfunction causing the applier to jam, and clip loading failures..

Recalling firm: Genicon, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2020-09-17
Firm location: Winter Park, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K030269 — GENICON CLIP APPLIERGenicon, LC·cleared 2003-03-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.