Device recall
Z-0595-2019: Xcela Power Injectable PICC with PASV (XCELA PASV 4F SL 55CM Catheter Kit CE…
FDA device recall · Class II · Angiodynamics Inc. (Navilyst Medical Inc.)
Key facts
| Recall number (Z-number) | Z-0595-2019 |
|---|---|
| Recall event | 81477 |
| Product | Xcela Power Injectable PICC with PASV (XCELA PASV 4F SL 55CM Catheter Kit CE PG), Cat no. 55-711 |
| Product code | LJS |
| Recalling firm | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 26, 2020 |
| 510(k) numbers | K091261 |
| FEI number | 3017892510 |
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