Device recall
Z-2309-2021: FLASH Ostial System, Dual Balloon Angioplasty Catheter, REF: OAB6014BA
FDA device recall · Class II · Ostial Corporation
Key facts
| Recall number (Z-number) | Z-2309-2021 |
|---|---|
| Recall event | 88334 |
| Product | FLASH Ostial System, Dual Balloon Angioplasty Catheter, REF: OAB6014BA |
| Product code | LIT |
| Recalling firm | Ostial Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 30, 2024 |
| 510(k) numbers | K122379 |
| FEI number | 3008700817 |
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