Device recall
Z-1188-2008: Reusable Ohmeda Compatible Finger Clip Sensor, Model Number: E403-02, Product…
FDA device recall · Class II · Kentec Medical Inc
Key facts
| Recall number (Z-number) | Z-1188-2008 |
|---|---|
| Recall event | 46397 |
| Product | Reusable Ohmeda Compatible Finger Clip Sensor, Model Number: E403-02, Product Code: PS2225. To monitor oxygen saturation level of patients under doctor's care. Kentec Medical Inc., Irvine, CA 92614 |
| Product code | DQA |
| Recalling firm | Kentec Medical Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 29, 2012 |
| 510(k) numbers | K970098 |
| FEI number | 2080225 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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