Device recall
Z-1121-2015: Pulsiocath PiCCO ProAQT Monitoring Kit, single-use cardiac output (CO) sensor…
FDA device recall · Class II · Pulsion Medical Inc
Key facts
| Recall number (Z-number) | Z-1121-2015 |
|---|---|
| Recall event | 69782 |
| Product | Pulsiocath PiCCO ProAQT Monitoring Kit, single-use cardiac output (CO) sensor, one unit per plastic sterilizable package. Product Usage: Measures cardiac output by the thermodilution method, measurement of arterial blood pressure, and for cardiac output determination by arterial pulse contour… |
| Product code | KRB |
| Recalling firm | Pulsion Medical Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 2, 2015 |
| 510(k) numbers | K991886 |
| FEI number | 3010289715 |
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