Device recall
Z-0341-2012: TC pCO2 Electrodes, Model/Part #945-655-E5260, 510(k) #K043003. Product Usage…
FDA device recall · Class II · Radiometer America Inc
Key facts
| Recall number (Z-number) | Z-0341-2012 |
|---|---|
| Recall event | 60153 |
| Product | TC pCO2 Electrodes, Model/Part #945-655-E5260, 510(k) #K043003. Product Usage: The device is intended for used with the firm's TCM series monitor. The E260mpCO2 electrode is a non-invasive device, used with the TCM series monitor to measure transcutaneous pCO2 (through the skin). |
| Product code | LKD |
| Recalling firm | Radiometer America Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 19, 2012 |
| 510(k) numbers | K043003 |
| FEI number | 1523456 |
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