Genicon Aquas PowerFlow Tube Set Recalled for Lack of FDA Clearance
Genicon, Inc. is recalling 10,808 units of the Aquas PowerFlow Tube Set because the device design did not receive proper premarket clearance from the FDA.
- 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
- Category
- Medical Device
- Distribution
- Distributed nationwide