Device recall
Z-0488-2018: BARD UROS AUTOMATED URINE OUPTUT AND TEMPERATURE MONITOR, MODEL BK10001M The…
FDA device recall · Class II · C.R. Bard, Inc.
Key facts
| Recall number (Z-number) | Z-0488-2018 |
|---|---|
| Recall event | 78231 |
| Product | BARD UROS AUTOMATED URINE OUPTUT AND TEMPERATURE MONITOR, MODEL BK10001M The Uros(TM) Automated Urine Output and Temperature Monitor is indicated to monitor urine output and core bladder temperature. |
| Product code | EXS |
| Recalling firm | C.R. Bard, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 7, 2021 |
| FEI number | 1018233 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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