Device recall
Z-2555-2014: The Thermedx Fluid Management System is designed to provide irrigation fluids to…
FDA device recall · Class II · Thermedx LLC
Key facts
| Recall number (Z-number) | Z-2555-2014 |
|---|---|
| Recall event | 68986 |
| Product | The Thermedx Fluid Management System is designed to provide irrigation fluids to irrigate, distend, and debride while warming the fluid to assist in the prevention of peri-operative hypothermia. The fluid is warmed via an internal infrared mechanism. Additionally the system will hold suction… |
| Product code | OJR |
| Recalling firm | Thermedx LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 4, 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