Device recall
Z-1971-2016: Vaxcel PICC with PASV Introducer Kit under the following labels: 1) 4F, UPN…
FDA device recall · Class II · Navilyst Medical, Inc., an AngioDyamics Company
Key facts
| Recall number (Z-number) | Z-1971-2016 |
|---|---|
| Recall event | 73598 |
| Product | Vaxcel PICC with PASV Introducer Kit under the following labels: 1) 4F, UPN M001455910, Rx ONLY The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, antibiotics… |
| Product code | LJS |
| Recalling firm | Navilyst Medical, Inc., an AngioDyamics Company |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 11, 2018 |
| 510(k) numbers | K021704 |
| FEI number | 3017892510 |
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