Device recall
Z-2032-2018: 9 Fr. Radiopaque Polyurethane Sheath/Dilator with Integral Hemostasis Valve/Side…
FDA device recall · Class II · Arrow International Inc
Key facts
| Recall number (Z-number) | Z-2032-2018 |
|---|---|
| Recall event | 79890 |
| Product | 9 Fr. Radiopaque Polyurethane Sheath/Dilator with Integral Hemostasis Valve/Side Port for use with 7 - 8 Fr. Catheters and Arrow Percutaneous Introducer System; Product codes: SS-09903-S |
| Product code | DYB |
| Recalling firm | Arrow International Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 15, 2020 |
| 510(k) numbers | K780532 |
| FEI number | 3015859709 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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