Class 2 Device Recall Aquas PowerFlow Tube Set

• Date Initiated by Firm: August 25, 2020
• Create Date: October 09, 2020
• Recall Status: Open, Classified
• Recall Number: Z-0094-2021
• Recall Event ID: 86173
• Product Classification: unknown device name - Product Code N/A
• 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
• Code Information: Model # 720-005-000 (BPSI SET WITH NO PROBE); Lot # I9214-C Model # 720-005-001 (BPSI SET 8 VENT PROBE); Lot Numbers: I8881-D I8873-D I9057-D I9058-D I9209-D I9213-D I9227-D I9235-D I9236-D I9237-D I9278-D I9280-D I9282-D I9283-D I9299-D I9309-D I9322-D I9324-D I9356-D I9358-D I9360-D I9361-D I9362-D I9363-D I9364-D I9365-D
• Recalling Firm/ Manufacturer: Genicon, Inc.; 6869 Stapoint Ct Ste 112; Winter Park FL 32792-6603
• For Additional Information Contact: Thomas Calcaterra; 407-657-4851
• Manufacturer Reason for Recall: 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 Determined 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 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: customerservice@geniconendo.com. 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 customerservice@geniconendo.com. (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: customerservice@geniconendo.com.
• Quantity in Commerce: 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.

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.