Device recall
Z-0534-2018: Covidien Vistec" X-Ray Detectable Sponges, 7317 Vistec" X-Ray Detectable Sponges…
FDA device recall · Class II · Covidien LP
Key facts
| Recall number (Z-number) | Z-0534-2018 |
|---|---|
| Recall event | 78968 |
| Product | Covidien Vistec" X-Ray Detectable Sponges, 7317 Vistec" X-Ray Detectable Sponges Sponge. product Usage: Vistec X-Ray Detectable Sponges are medical absorbent devices intended to be used internally within the body cavity to control bleeding or for applying medication. These sponges contain unique… |
| Product code | GDY |
| Recalling firm | Covidien LP |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 14, 2018 |
| FEI number | 1018120 |
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