Device recall
Z-2395-2020: BioFlo Midline Catheter and BioFlo Maximal Barrier Kits - Product Usage: These…
FDA device recall · Class II · Angiodynamics, Inc.
Key facts
| Recall number (Z-number) | Z-2395-2020 |
|---|---|
| Recall event | 85631 |
| Product | BioFlo Midline Catheter and BioFlo Maximal Barrier Kits - Product Usage: These introducers are used for the percutaneous introduction of diagnostic or therapeutic devices, such as catheters or pacing leads in the vasculature. Item Numbers H965460151 H965460161 H965460161-NP H965460171 H965460181… |
| Product code | FOZ |
| 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