Device recall
Z-0094-2021: Aquas PowerFlow Tube Set - Product Usage: The device delivers sterile irrigation…
FDA device recall · Class II · Genicon, Inc.
Key facts
| Recall number (Z-number) | Z-0094-2021 |
|---|---|
| Recall event | 86173 |
| 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 |
| Recalling firm | Genicon, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 3002590791 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database