Device recall
Z-1599-2015: VenaSeal, Sapheon Closure System, Model # SP-101, VS-301 and VS-402. For…
FDA device recall · Class II · Covidien LLC
Key facts
| Recall number (Z-number) | Z-1599-2015 |
|---|---|
| Recall event | 71138 |
| Product | VenaSeal, Sapheon Closure System, Model # SP-101, VS-301 and VS-402. For vascular use. |
| Product code | PJQ |
| Recalling firm | Covidien LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 29, 2016 |
| PMA numbers | P140018 |
| FEI number | 1282497 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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