FDA-Device2020-10-21Class II
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
Genicon, Inc.
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).
Sold states
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.
Affected count
10808 units
Manufactured in
6869 Stapoint Ct Ste 112, N/A, Winter Park, FL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0094-2021Don't want to check this manually?
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