Device recall
Z-1376-2021: Regard, Item Number 830067009, custom cardiovascular procedure kit
FDA device recall · Class II · ROi CPS LLC
Key facts
| Recall number (Z-number) | Z-1376-2021 |
|---|---|
| Recall event | 87472 |
| Product | Regard, Item Number 830067009, custom cardiovascular procedure kit |
| Product code | OEZ |
| Recalling firm | ROi CPS LLC |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 3014527682 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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