Device recall
Z-0736-2022: CoolSeal Generator, REF: CSL-200-50
FDA device recall · Class II · Bolder Surgical, LLC
Key facts
| Recall number (Z-number) | Z-0736-2022 |
|---|---|
| Recall event | 89570 |
| Product | CoolSeal Generator, REF: CSL-200-50 |
| Product code | GEI |
| Recalling firm | Bolder Surgical, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 15, 2024 |
| 510(k) numbers | K202114 |
| FEI number | 3010377594 |
At a glance
- 1–9 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