Device recall
Z-1064-2013: Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 30…
FDA device recall · Class II · Arrow International Inc
Key facts
| Recall number (Z-number) | Z-1064-2013 |
|---|---|
| Recall event | 64527 |
| Product | Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 30 cc; Product Number: IAB-05830-LWS. The IAB is utilized for intra-aortic balloon counter-pulsation therapy. |
| Product code | DSP |
| Recalling firm | Arrow International Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 2, 2015 |
| 510(k) numbers | K000729, K021462 |
| FEI number | 3015859709 |
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