Device recall
Z-2680-2016: NIO-A / NIO-P is an instant IO access device comprises housing with spring load…
FDA device recall · Class II · Waismed Ltd
Key facts
| Recall number (Z-number) | Z-2680-2016 |
|---|---|
| Recall event | 75008 |
| Product | NIO-A / NIO-P is an instant IO access device comprises housing with spring load mechanism that injects a trocar needle into the bone marrow of a patient and allows connection of syringe or IV administration set. The NIO-A is intended for adults above 12 years old and the NIO-P is intended for… |
| Product code | FMI |
| Recalling firm | Waismed Ltd |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 5, 2016 |
| 510(k) numbers | K160805 |
| FEI number | 3011989505 |
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