Drug recall
The Natus Cranial Access Kit is designed to be a complete, single use and disposable accessory and…
FDA recall event 91193 · Class II · Natus Medical Incorporated
Key facts
| Event ID | 91193 |
|---|---|
| Recall numbers | Z-0735-2023 |
| Recalling firm | Natus Medical Incorporated |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Due to Cranial Access Kits containing recalled sterile surgical drapes. The sterile surgical drapes are being recalled due to the liner on the adhesive component is difficult to remove without… |
| Initiation date | Nov 18, 2022 |
| Report date | Dec 28, 2022 |
| City | San Diego |
| State | CA |
| Country | United States |
| FEI number | 2023988 |
At a glance
- 1–9 Products in this recall
- 1–9 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: