Device recall
Z-1431-2010: Unilect ECG Electrodes Unomedical, McAllen Texas. Intended use:Cardiac…
FDA device recall · Class II · ConvaTec
Key facts
| Recall number (Z-number) | Z-1431-2010 |
|---|---|
| Recall event | 54975 |
| Product | Unilect ECG Electrodes Unomedical, McAllen Texas. Intended use:Cardiac monitoring |
| Product code | DRX |
| Recalling firm | ConvaTec |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 21, 2011 |
| 510(k) numbers | K990113 |
| FEI number | 3011987967 |
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