Device recall
Z-1208-2017: Maquet Express Dry Seal Suction Chest Drain, Single Collection w/AC Reference…
FDA device recall · Class II · Atrium Medical Corporation
Key facts
| Recall number (Z-number) | Z-1208-2017 |
|---|---|
| Recall event | 75707 |
| Product | Maquet Express Dry Seal Suction Chest Drain, Single Collection w/AC Reference: 4000-100N Intended Use: 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… |
| Product code | CAC |
| Recalling firm | Atrium Medical Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 3, 2020 |
| 510(k) numbers | K043140, K984496 |
| 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