Device recall
Z-0235-2019: Altrix Precision Temperature Management System Model: 8001Product Usage: The…
FDA device recall · Class II · Stryker Medical Division of Stryker Corporation
Key facts
| Recall number (Z-number) | Z-0235-2019 |
|---|---|
| Recall event | 81103 |
| Product | Altrix Precision Temperature Management System Model: 8001Product Usage: The Altrix system is intended for circulating temperature controlled warm or cold water via patient contact thermal transfer devices for the application of regulating human body temperature in situations where a physician or… |
| Product code | DWJ |
| Recalling firm | Stryker Medical Division of Stryker Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 13, 2020 |
| 510(k) numbers | K152266, K180834 |
| FEI number | 1831750 |
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