Device recall
Z-2776-2015: Edwards Pressure Monitoring Kit with TruWave disposable pressure transducer. A…
FDA device recall · Class II · Edward Lifesciences, Llc
Key facts
| Recall number (Z-number) | Z-2776-2015 |
|---|---|
| Recall event | 71971 |
| Product | Edwards Pressure Monitoring Kit with TruWave disposable pressure transducer. A sterile, single-use kit that monitors pressures when attached to pressure monitoring catheters. For use on patients requiring intravascular, intracranial, or intrauterine pressure monitoring. |
| Product code | DXO |
| Recalling firm | Edward Lifesciences, Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 8, 2016 |
| 510(k) numbers | K142749 |
| FEI number | 2015691 |
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