Device recall
Z-0735-2023: The Natus Cranial Access Kit is designed to be a complete, single use and…
FDA device recall · Class II · Natus Medical Incorporated
Key facts
| Recall number (Z-number) | Z-0735-2023 |
|---|---|
| Recall event | 91193 |
| Product | The Natus Cranial Access Kit is designed to be a complete, single use and disposable accessory and instrumentation set that is used to create an intracranial burr-hole typically required for procedures such as ventriculostomy or intracranial pressure (ICP) monitoring. The various components of the… |
| Product code | PSP |
| Recalling firm | Natus Medical Incorporated |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 2023988 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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