Device recall
Z-0578-2017: Atrium Medical 12 Fr Trocar catheter, Sterile Model Number: 8412 Intended to…
FDA device recall · Class II · Atrium Medical Corporation
Key facts
| Recall number (Z-number) | Z-0578-2017 |
|---|---|
| Recall event | 75347 |
| Product | Atrium Medical 12 Fr Trocar catheter, Sterile Model Number: 8412 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum. |
| Product code | GBZ |
| Recalling firm | Atrium Medical Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 9, 2018 |
| 510(k) numbers | K831931 |
| FEI number | 3011175548 |
At a glance
- 1–9 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