Device recall
Z-0963-2019: Hermes NC PTA Balloon Dilatation Catheter The balloon dilatation catheter is…
FDA device recall · Class II · BrosMed Medical Co.,Ltd.
Key facts
| Recall number (Z-number) | Z-0963-2019 |
|---|---|
| Recall event | 81973 |
| Product | Hermes NC PTA Balloon Dilatation Catheter The balloon dilatation catheter is intended to dilate stenoses in the iliac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device… |
| Product code | LIT |
| Recalling firm | BrosMed Medical Co.,Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 11, 2020 |
| 510(k) numbers | K160941 |
| FEI number | 3010391265 |
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