Device recall
Z-1463-2015: Fluid Management System P4000; for irrigation and fluid warming in laparoscopic…
FDA device recall · Class II · Thermedx LLC
Key facts
| Recall number (Z-number) | Z-1463-2015 |
|---|---|
| Recall event | 69996 |
| Product | Fluid Management System P4000; for irrigation and fluid warming in laparoscopic procedures, and distention, fluid warming, and volume/deficit measurements in endoscopic procedures within gynecology, urology, and orthopedic procedures. |
| Product code | HIG |
| Recalling firm | Thermedx LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 14, 2015 |
| 510(k) numbers | K091939, K133799 |
| FEI number | 3007495879 |
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