Device recall
Z-1590-2018: StoneBreaker Pneumatic Lithotripter, Catalog number: SBL-KIT1; GPN: G52604…
FDA device recall · Class II · Cook Inc.
Key facts
| Recall number (Z-number) | Z-1590-2018 |
|---|---|
| Recall event | 79731 |
| Product | StoneBreaker Pneumatic Lithotripter, Catalog number: SBL-KIT1; GPN: G52604 UDI:(01)00827002526044 |
| Product code | FFK |
| Recalling firm | Cook Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 17, 2020 |
| 510(k) numbers | K062475 |
| FEI number | 1820334 |
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