Device recall
Z-0760-2016: Arctic Sun 5000 and Arctic Sun 2000; Intended for monitoring and controlling…
FDA device recall · Class II · C.R. Bard, Inc.
Key facts
| Recall number (Z-number) | Z-0760-2016 |
|---|---|
| Recall event | 72756 |
| Product | Arctic Sun 5000 and Arctic Sun 2000; Intended for monitoring and controlling patient temperatures. |
| Product code | DWJ |
| Recalling firm | C.R. Bard, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 21, 2017 |
| 510(k) numbers | K071341, K101092 |
| 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