Recall Z-0094-2021 · N/A

Genicon, Inc.

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

Date	Aug 25, 2020
Status	Open, Classified
Reason	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).
Root cause	Device Design
Action	Genicon issued an updated urgent medical device recall notification on August 29,2020 and initial urgent medical device recall notification was sent on August 24, 2020. The notification states the following action to be taken: To Distributors: Please encourage your customers to complete and return the enclosed response form as soon as possible and return the form by e-mail to customerservice@geniconendo.com. In addition, if you or your customers have any of the affected devices, contact Genicon Customer Service , to coordinate the return of the product associated with this action at no add
Quantity	10808 units
Distribution	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.
FDA record	Open on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.