Device recall
Z-1284-2021: CAIRE DIAGNOSTICS FenomPro REF 900-0001 SN ***** - Product Usage: a portable…
FDA device recall · Class II · CAIRE DIAGNOSTICS INC
Key facts
| Recall number (Z-number) | Z-1284-2021 |
|---|---|
| Recall event | 87445 |
| Product | CAIRE DIAGNOSTICS FenomPro REF 900-0001 SN ***** - Product Usage: a portable, non-invasive device to measure fractional exhaled nitric oxide (FeNO) in human breath. Fenom Pro should not be used in critical care, emergency care or in anesthesiology. |
| Product code | MXA |
| Recalling firm | CAIRE DIAGNOSTICS INC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 24, 2023 |
| 510(k) numbers | K182874 |
| FEI number | 3013216353 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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