Device recall
Z-0123-2016: The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for…
FDA device recall · Class II · Clinical Innovations, LLC
Key facts
| Recall number (Z-number) | Z-0123-2016 |
|---|---|
| Recall event | 72018 |
| Product | The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for use in providing temporary control or reduction of postpartum uterine bleeding. |
| Product code | OQY |
| Recalling firm | Clinical Innovations, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 21, 2016 |
| 510(k) numbers | K150573 |
| FEI number | 1000220650 |
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