Device recall
Z-1395-2016: BARD ArcticGel Pads Product Usage: The Arctic Sun Temperature Management System…
FDA device recall · Class II · C.R. Bard, Inc.
Key facts
| Recall number (Z-number) | Z-1395-2016 |
|---|---|
| Recall event | 73454 |
| Product | BARD ArcticGel Pads Product Usage: The Arctic Sun Temperature Management System is intended for monitoring and controlling patient temperature. ArcticGel Pads are only for use with an Arctic Sun Temperature Management System Control Module. |
| Product code | DWJ |
| Recalling firm | C.R. Bard, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 7, 2017 |
| 510(k) numbers | K142702 |
| 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