Device recall
Z-2615-2016: FluoroSet Radiographic Tubal Assessment Set Cannula, Manipulator/ Injector…
FDA device recall · Class II · Cook Inc.
Key facts
| Recall number (Z-number) | Z-2615-2016 |
|---|---|
| Recall event | 74010 |
| Product | FluoroSet Radiographic Tubal Assessment Set Cannula, Manipulator/ Injector, Uterine Used for instillation of contrast media into the uterine cavity for radiographic evaluation of the uterine cavity and for injection of appropriate contrast media into the fallopian tubes for evaluation of tubal… |
| Product code | LFK |
| Recalling firm | Cook Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 4, 2017 |
| FEI number | 1820334 |
At a glance
- None Linked 510(k)s
- 10–99 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