Device recall
Z-0524-2021: Regard - Product Usage: Obstetric Gynecologic specialized manual instrument…
FDA device recall · Class II · ROi CPS LLC
Key facts
| Recall number (Z-number) | Z-0524-2021 |
|---|---|
| Recall event | 86626 |
| Product | Regard - Product Usage: Obstetric Gynecologic specialized manual instrument. Labor and delivery kits. |
| Product code | MLS |
| Recalling firm | ROi CPS LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 13, 2021 |
| FEI number | 3014527682 |
At a glance
- None 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