Device recall
Z-0223-2016: FLAIR Endovascular Stent Graft, Product Code: FAS08070, FAF08070, Implant Size…
FDA device recall · Class II · Bard Peripheral Vascular Inc
Key facts
| Recall number (Z-number) | Z-0223-2016 |
|---|---|
| Recall event | 72459 |
| Product | FLAIR Endovascular Stent Graft, Product Code: FAS08070, FAF08070, Implant Size: 8mmx70mm The FLAIR Endovascular Stent Graft (implant) is a flexible, self-expanding endoprosthesis comprised of expanded polytetrafluoroethylene (ePTFE) encapsulating a Nitinol stent framework. The FLAIR Endovascular… |
| Product code | MIH |
| Recalling firm | Bard Peripheral Vascular Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 12, 2016 |
| PMA numbers | P060002 |
| FEI number | 2020394 |
At a glance
- None 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