Device recall
Z-1064-2016: Super Arrow-Flex Percutaneous Sheath Introducer Sets REF CL-07035 or CL-07635 or…
FDA device recall · Class II · Arrow International Inc
Key facts
| Recall number (Z-number) | Z-1064-2016 |
|---|---|
| Recall event | 73045 |
| Product | Super Arrow-Flex Percutaneous Sheath Introducer Sets REF CL-07035 or CL-07635 or CL-07735 or CL-07835 Super Arrow-Flex Percutaneous Sheath Introducer Set with Integral Hemostasis Valve/Side Port and Radiopaque Tip Marker Band Contents: 1: . . . . . . . . . Sheath*: *** Super Arrow-Flex Radiopaque… |
| Product code | DYB |
| Recalling firm | Arrow International Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 26, 2018 |
| 510(k) numbers | K924607 |
| 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