Device recall
Z-1952-2019: Revive Reusable Bladder Support, Model No. 0025 - Product Usage: The Revive…
FDA device recall · Class II · Rinovum Women's Health
Key facts
| Recall number (Z-number) | Z-1952-2019 |
|---|---|
| Recall event | 83023 |
| Product | Revive Reusable Bladder Support, Model No. 0025 - Product Usage: The Revive bladder support is intended for temporary management of urinary leakage caused by stress urinary incontinence (SUI) in women, 18 years and older. The device comes in a sealed box, and contains a reusable bladder support and… |
| Product code | HHW |
| Recalling firm | Rinovum Women's Health |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 12, 2019 |
| 510(k) numbers | K183468 |
| FEI number | 3015417614 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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