Device recall
Z-1288-2018: Southmedic Oxygen Masks with EtCO2 sampling line part number OM-2125-8, 25 masks…
FDA device recall · Class II · Southmedic, Inc.
Key facts
| Recall number (Z-number) | Z-1288-2018 |
|---|---|
| Recall event | 78568 |
| Product | Southmedic Oxygen Masks with EtCO2 sampling line part number OM-2125-8, 25 masks per case. Minimal contact, open oxygen delivery device for use with USP medical grade oxygen and for monitoring breathing by providing a means to sample exhaled CO2. |
| Product code | CCK |
| Recalling firm | Southmedic, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 29, 2024 |
| 510(k) numbers | K014211 |
| FEI number | 3001717360 |
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