Device recall
Z-2536-2018: Arctic Sun Temperature Management System, Model 5000. The Arctic Sun 5000 model…
FDA device recall · Class II · Bard Medical Division
Key facts
| Recall number (Z-number) | Z-2536-2018 |
|---|---|
| Recall event | 80375 |
| Product | Arctic Sun Temperature Management System, Model 5000. The Arctic Sun 5000 model is a non-invasive, thermal regulating system, indicated for monitoring and controlling patient temperature within a range of 32C to 38.5C (89.6F to 101.3F) in adult and pediatric patients of all ages. |
| Product code | DWJ |
| Recalling firm | Bard Medical Division |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 16, 2021 |
| 510(k) numbers | K161602 |
| FEI number | 1018233 |
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