Device recall
Z-2133-2019: Nasal Alar SpO2 Sensor, Adult/Pediatric SpO2 Sensor, Rx Only Product Usage: The…
FDA device recall · Class II · Xhale Assurance, Inc.
Key facts
| Recall number (Z-number) | Z-2133-2019 |
|---|---|
| Recall event | 82817 |
| Product | Nasal Alar SpO2 Sensor, Adult/Pediatric SpO2 Sensor, Rx Only Product Usage: The Assurance Nasal Alar SpO2 Sensor is indicated for single patient use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate from the nasal ala of adult and… |
| Product code | DQA |
| Recalling firm | Xhale Assurance, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 25, 2022 |
| 510(k) numbers | K143216, K171423 |
| FEI number | 1000113495 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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