Device recall
Z-0969-2017: Halo One 5F Introducer Sheath 90 cm Product Code: HAL590 Product Usage: The Halo…
FDA device recall · Class I · BARD PERIPHERAL VASCULAR, INC
Key facts
| Recall number (Z-number) | Z-0969-2017 |
|---|---|
| Recall event | 75875 |
| Product | Halo One 5F Introducer Sheath 90 cm Product Code: HAL590 Product Usage: The Halo One Thin-Walled Guiding Sheath is designed to perform as both a guiding sheath and introducer sheath. The Halo One Thin-Walled Guiding Sheath is indicated for use in peripheral arterial and venous procedures requiring… |
| Product code | DYB |
| Recalling firm | BARD PERIPHERAL VASCULAR, INC |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Apr 5, 2017 |
| 510(k) numbers | K161183 |
| FEI number | 3000131337 |
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