Device recall
Z-1158-2018: Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port…
FDA device recall · Class II · Arrow International Inc
Key facts
| Recall number (Z-number) | Z-1158-2018 |
|---|---|
| Recall event | 79342 |
| Product | Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters. Permits venous access and catheter introduction to the central circulation. |
| Product code | DYB |
| Recalling firm | Arrow International Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 15, 2019 |
| 510(k) numbers | K780532 |
| FEI number | 3015859709 |
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