Drug recall
NIO-A / NIO-P is an instant IO access device comprises housing with spring load mechanism that injects a…
FDA recall event 75008 · Class II · Waismed Ltd
Key facts
| Event ID | 75008 |
|---|---|
| Recall numbers | Z-2680-2016 |
| Recalling firm | Waismed Ltd |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | WaisMed received a report in which during the operation of the NIO-A, the needle was not released from the device as expected. The device was placed on the floor and after several minutes the needle… |
| Initiation date | Aug 18, 2016 |
| Report date | Sep 7, 2016 |
| Termination date | Dec 5, 2016 |
| City | Rosh Haayin |
| Country | Israel |
| FEI number | 3011989505 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: