Device recall
Z-0515-2021: Capnostream 35 Portable Respiratory Monitor, Product numbers PM35MN02, PM35MN01…
FDA device recall · Class II · Covidien Llc
Key facts
| Recall number (Z-number) | Z-0515-2021 |
|---|---|
| Recall event | 86829 |
| Product | Capnostream 35 Portable Respiratory Monitor, Product numbers PM35MN02, PM35MN01, PM35MN05, DLPM35MN02 - Product Usage: use during both no motion and motion conditions and for patients who are well or poorly perfused. |
| Product code | CCK |
| Recalling firm | Covidien Llc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K150272 |
| FEI number | 1282497 |
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