FDA Device recall Z-0735-2023
The Natus Cranial Access Kit is designed to be a complete, single use and disposable accessory and instrumentation set that is used to crea…
- FDA Device
- Class II
- ongoing
- Published 2022-12-28
On 2022-12-28 the FDA classified a Class II recall of The Natus Cranial Access Kit is designed to be a complete, single use and disposable accessory and instrumentation set that is used to crea… by Natus Medical, citing 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 r….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0735-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-11-18 |
| Published | 2022-12-28 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Natus Medical |
| Distribution | US |
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 kit are comprised to make it convenient for the practitioner to have all that they need in one place for fast and efficient intracranial access. cerebral spinal fluid (CSF).
Reason
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 damaging the product and may render the product unusable.
Identifiers
| code_info | Part Number: HITH1 UDI-DI Code: 382830048590 Lot Number: 22GDB675 Part Number: HITHNDRZR UDI-DI Code: 382830048620 Lot…Part Number: HITH1 UDI-DI Code: 382830048590 Lot Number: 22GDB675 Part Number: HITHNDRZR UDI-DI Code: 382830048620 Lot Number: 22HDA557 Part Number: HITHLT UDI-DI Code: 382830048637 Lot Number: 22IDB724 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0735-2023%22
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