Device recall
Z-1347-2012: Oridion Surestream CO2 Sampling Lines- Smart SureLine Plus O2 adult Part Number…
FDA device recall · Class II · Oridion Medical 1987 Ltd.
Key facts
| Recall number (Z-number) | Z-1347-2012 |
|---|---|
| Recall event | 61143 |
| Product | Oridion Surestream CO2 Sampling Lines- Smart SureLine Plus O2 adult Part Number: 010981-03 Product Usage: The intended use of SureStream sampling lines is to convey a sample of a patients expired breath to a capnograph in order to measure CO2 partial pressure in intubated and non intubated patients. |
| Product code | CCK |
| Recalling firm | Oridion Medical 1987 Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 4, 2012 |
| 510(k) numbers | K012391 |
| 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