Device recall
Z-1057-2013: Arrow/Teleflex Medical Berman Angiographic Balloon Catheter and Reverse Berman…
FDA device recall · Class II · Arrow International Inc
Key facts
| Recall number (Z-number) | Z-1057-2013 |
|---|---|
| Recall event | 64593 |
| Product | Arrow/Teleflex Medical Berman Angiographic Balloon Catheter and Reverse Berman Angiographic Balloon Catheter. The Arrow Berman(TM) Angiographic Catheter is indicated for use in right heart catheterization for cardiac angiography, and measurement of the right heart and pulmonary artery pressures. It… |
| Product code | DYG |
| Recalling firm | Arrow International Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 21, 2013 |
| 510(k) numbers | K892530 |
| FEI number | 3015859709 |
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