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Genicon, Inc. recalls Aquas PowerFlow Tube Set - Product Usage: The device delivers sterile irrigation fluids to surgical sites during laparos
Recalled October 21, 2020 · FDA recall Z-0094-2021 · Genicon
Hazard
The product design incorporating a motor driven impeller pump powered by one 9V alkaline battery inside the hand-piece did not receive proper premarket clearance from US FDA and lacks a 510(k). · FDA Class II
Units
10808 units
Sold at
Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, IA, IL, IN, MA, MI, MO, NC, OH, TN, VA, WA, WI and the countries of ECUADOR, HONG KONG, QATAR, SAUDI ARABIA, UAE (Dubai), JORDAN, KUWAIT, SOUTH AFRICA.
Description
The product design incorporating a motor driven impeller pump powered by one 9V alkaline battery inside the hand-piece did not receive proper premarket clearance from US FDA and lacks a 510(k).
Product
Aquas PowerFlow Tube Set - Product Usage: The device delivers sterile irrigation fluids to surgical sites during laparoscopic procedures and to evacuate blood, tissue debris, and smoke from the surgical site
Manufacturer(s)
Genicon, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →