Device recall
Z-1334-2012: Oridion CO2 sampling lines and water traps under the label: Omnistream CO2…
FDA device recall · Class II · Oridion Medical 1987 Ltd.
Key facts
| Recall number (Z-number) | Z-1334-2012 |
|---|---|
| Recall event | 61329 |
| Product | Oridion CO2 sampling lines and water traps under the label: Omnistream CO2 Sampling Lines: OmniLine O2 Adult Part No.007609; OmniLine O2 Pediatric Part No 007610; Smart OmniLine Plus O2 Adult Part No.010177; Smart OmniLine Plus O2 Adult (package of 100 units) Part No.010213; Smart OmniLine O2… |
| Product code | CCK |
| Recalling firm | Oridion Medical 1987 Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 13, 2013 |
| 510(k) numbers | K012395, K013845, K042665, K093388, K980324 |
| FEI number | 3001227743 |
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