Device recall
Z-0076-2019: BioFlo Port with ENDEXO and PASV Technology-AngioDynamics BIOFLO 8F SINGLE…
FDA device recall · Class II · Angiodynamics Inc. (Navilyst Medical Inc.)
Key facts
| Recall number (Z-number) | Z-0076-2019 |
|---|---|
| Recall event | 80913 |
| Product | BioFlo Port with ENDEXO and PASV Technology-AngioDynamics BIOFLO 8F SINGLE PLASTIC NON-FILLED; VALVED PG UPN: H965440210 Catalog Number: 44-021 Box of 1 Port - Product Usage - Long-term access to the central venous system for administration of fluids including but not limited to hydration fluids… |
| Product code | LJT |
| Recalling firm | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 17, 2019 |
| 510(k) numbers | K131694 |
| 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