Device recall
Z-0007-2013: BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit…
FDA device recall · Class II · Invuity, Inc.
Key facts
| Recall number (Z-number) | Z-0007-2013 |
|---|---|
| Recall event | 62966 |
| Product | BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source. |
| Product code | JOL |
| Recalling firm | Invuity, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 23, 2013 |
| FEI number | 3007037347 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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