Device recall
Z-0307-2022: The Ocean Water Seal Chest Drain is a plastic, three bottle vacuum collection…
FDA device recall · Class II · Atrium Medical Corporation
Key facts
| Recall number (Z-number) | Z-0307-2022 |
|---|---|
| Recall event | 88923 |
| Product | The Ocean Water Seal Chest Drain is a plastic, three bottle vacuum collection device. It consists of a collection chamber that holds shed mediastinal blood, a water seal chamber using a water seal that prevents air from entering into the pleural space and a suction control chamber, which… |
| Product code | KDQ |
| Recalling firm | Atrium Medical Corporation |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K043582 |
| 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