Device recall
Z-2767-2016: Sterile Drape, SK6000 PAQ drape pouch (for use with the SPY Fluorescent System…
FDA device recall · Class II · NOVADAQ TECHNOLOGIES INC.
Key facts
| Recall number (Z-number) | Z-2767-2016 |
|---|---|
| Recall event | 75006 |
| Product | Sterile Drape, SK6000 PAQ drape pouch (for use with the SPY Fluorescent System (SPY 2000/2001)) The SPY Fluorescent Imaging System is intended to provide fluorescent images for the visual assessment of blood flow in vessels and related tissue perfusion during cardiovascular surgical procedures. For… |
| Product code | IZI |
| Recalling firm | NOVADAQ TECHNOLOGIES INC. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 9, 2016 |
| 510(k) numbers | K042961, K060867, K063345, K071037, K071619, K072222 |
| FEI number | 3012345110 |
At a glance
- 1–9 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