Device recall
Z-2397-2020: BioFlo PICC and Xcela PICC Convenience Kits - Product Usage: are indicated for…
FDA device recall · Class II · Angiodynamics, Inc.
Key facts
| Recall number (Z-number) | Z-2397-2020 |
|---|---|
| Recall event | 85631 |
| Product | BioFlo PICC and Xcela PICC Convenience Kits - Product Usage: are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power… |
| Product code | LJS |
| Recalling firm | Angiodynamics, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 23, 2023 |
| FEI number | 1319211 |
At a glance
- None 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