Device recall
Z-0297-2017: The PAXWIRE Occlusion Balloon System consists of an occlusion catheter…
FDA device recall · Class II · AccessClosure, Inc., A Cardinal Health Company
Key facts
| Recall number (Z-number) | Z-0297-2017 |
|---|---|
| Recall event | 75376 |
| Product | The PAXWIRE Occlusion Balloon System consists of an occlusion catheter, inflation handle and syringes. It is designed for use in the iliofemoral artery to provide temporary occlusion as well as a path for dilator and/or sheath introduction, removal or repositioning during catheterization procedures. |
| Product code | MJN |
| Recalling firm | AccessClosure, Inc., A Cardinal Health Company |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 14, 2016 |
| 510(k) numbers | K143613 |
| FEI number | 3010142363 |
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