Device recall
Z-1436-06: D826 Accessory kit for single tcpO2 Electrodes for use with the TCM400…
FDA device recall · Class II · Radiometer America Inc
Key facts
| Recall number (Z-number) | Z-1436-06 |
|---|---|
| Recall event | 35789 |
| Product | D826 Accessory kit for single tcpO2 Electrodes for use with the TCM400 Transcutaneous Monitor (Cutaneous Oxygen Monitor) |
| Product code | KLK |
| Recalling firm | Radiometer America Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 25, 2012 |
| 510(k) numbers | K001866 |
| FEI number | 1523456 |
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