Device recall
Z-1982-2016: BioFlo PICC with ENDEXO and PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN…
FDA device recall · Class II · Navilyst Medical, Inc., an AngioDyamics Company
Key facts
| Recall number (Z-number) | Z-1982-2016 |
|---|---|
| Recall event | 73598 |
| Product | BioFlo PICC with ENDEXO and PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965458430 & UPN H965458840, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous… |
| 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