Device recall
Z-1219-2020: The Bard Intra-abdominal Pressure Monitoring Device is composed of a tubing set…
FDA device recall · Class II · C.R. Bard Inc
Key facts
| Recall number (Z-number) | Z-1219-2020 |
|---|---|
| Recall event | 84744 |
| Product | The Bard Intra-abdominal Pressure Monitoring Device is composed of a tubing set used for infusing fluid into the urinary bladder through the Foley catheter sampling port. It utilizes a clamping device to occlude the urinary drainage tubing to form a fluid column through which pressure is measured. |
| Product code | PHU |
| Recalling firm | C.R. Bard Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 12, 2021 |
| 510(k) numbers | K070201 |
| FEI number | 1018233 |
At a glance
- 1–9 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