Device recall
Z-2194-2018: Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved with Nitinol GW PG, Catalog Number…
FDA device recall · Class II · Angiodynamics Inc. (Navilyst Medical Inc.)
Key facts
| Recall number (Z-number) | Z-2194-2018 |
|---|---|
| Recall event | 80169 |
| Product | Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved with Nitinol GW PG, Catalog Number 45-887 |
| Product code | LJS |
| Recalling firm | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 13, 2020 |
| 510(k) numbers | K142616 |
| 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