Device recall
Z-1680-2015: D-fend, (p/n 876446-HEL), and D-fend+ (p/n 881319-HEL) water trap. Used with…
FDA device recall · Class II · GE Healthcare
Key facts
| Recall number (Z-number) | Z-1680-2015 |
|---|---|
| Recall event | 71044 |
| Product | D-fend, (p/n 876446-HEL), and D-fend+ (p/n 881319-HEL) water trap. Used with Compact Airway Modules E/M-C(Ai)O(V)(X) and Cardiocap/5 monitors. Product Usage: Water traps are intended to protect the GE monitor from humidity, secretions and bacterial contamination when monitoring respiratory… |
| Product code | CCL |
| Recalling firm | GE Healthcare |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 7, 2016 |
| 510(k) numbers | K051092 |
| FEI number | 2126677 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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