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
Recall
- Recall Number
- Z-0094-2021
- Event Number
- 86173
- Firm
- Genicon, Inc.
- FEI Number
- 3002590791
- Product Code
- N/A
- Status
- Open, Classified
- Root Cause
- Device Design
- Initiated
- August 25, 2020
- Address
- 6869 Stapoint Ct, Ste 112, Winter Park, FL, 32792-6603
Description
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
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).
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 [email protected]. 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 additional cost. Genicon Customer Service Contact Information Genicon Customer Service Manager +1-407-657-4851, extension #800, Monday through Thursday 9AM-4PM USA Eastern Time Zone. E-mail: [email protected]. To Users: (1)Please confirm whether any of the affected product remains in your inventory by completing the attached Medical Device Recall Response Form and e-mailing it to [email protected]. (2) Should you find affected product in your inventory, do not use them. (3)Please return affected product to Genicon, Inc. (see below contact details). Genicon Customer Service Manager (contact information below) to coordinate the return at no additional cost. NAME, Genicon Customer Service Manager +1-407-657-4851, extension #800, Monday through Thursday 9AM-4PM USA Eastern Time Zone. E-mail: [email protected].
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.
10808 units