Device recall
Z-3197-2018: ARROW Bipolar Electrode Catheter with shrouded pins, 6 Fr, 110 cm Product Code…
FDA device recall · Class II · Arrow International Inc
Key facts
| Recall number (Z-number) | Z-3197-2018 |
|---|---|
| Recall event | 80872 |
| Product | ARROW Bipolar Electrode Catheter with shrouded pins , 6 Fr, 110 cm Product Code: AI-06210-S Product Usage: Arrow electrophysiology catheters are intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording |
| Product code | DRF |
| Recalling firm | Arrow International Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 11, 2019 |
| 510(k) numbers | K945229 |
| 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