Recall Z-0094-2021— Genicon, Inc.
Class II · Ongoing
Class II FDA medical device recall by Genicon, Inc., initiated 2020-08-25. FDA's recall record names no specific 510(k) clearance for this event. 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. 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)..
- Recalling firm
- Genicon, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2020-08-25
- Firm location
- Winter Park, FL, United States
Product 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
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.