Device recall
Z-1088-2017: Atrium Medical 16400 Express Mini 500 dry seal drain Product Usage: To evacuate…
FDA device recall · Class II · Atrium Medical Corporation
Key facts
| Recall number (Z-number) | Z-1088-2017 |
|---|---|
| Recall event | 75599 |
| Product | Atrium Medical 16400 Express Mini 500 dry seal drain Product Usage: To evacuate air and/or fluid from the chest cavity or mediastinum. To help re-establish lung expansion and restore breathing dynamics. To facilitate postoperative collection and reinfusion of autologous blood from the patient s… |
| Product code | PAD |
| Recalling firm | Atrium Medical Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 29, 2020 |
| FEI number | 3011175548 |
At a glance
- None Linked 510(k)s
- 10–99 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