Device recall
Z-1333-2012: Oridion CO2 sampling lines and water traps under the label: Surestream CO2…
FDA device recall · Class II · Oridion Medical 1987 Ltd.
Key facts
| Recall number (Z-number) | Z-1333-2012 |
|---|---|
| Recall event | 61329 |
| Product | Oridion CO2 sampling lines and water traps under the label: Surestream CO2 Sampling Lines: SureLine Adult Part No.010976; sureLine Pediatric Part No. 010977; SureLine O2 Adult Part No.010979; SureLine O2 Pediatric Part No.010980 Smart SureLine Plus O2 Adult Part No. 010981; Smart SureLine O2… |
| Product code | CCK |
| Recalling firm | Oridion Medical 1987 Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 13, 2013 |
| 510(k) numbers | K012391, K012395, K013845, K042665, K980324, K980327 |
| 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