Z-0735-2023Class II

The Natus Cranial Access Kit is designed to be a complete, single use and disposable accessory and...

Name: Z-0735-2023 The Natus Cranial Access Kit is designed to be a complete, single use and disposable accessory and...
Creator: Natus Medical Incorporated
Published: 2022-11-18
License: https://open.fda.gov/license/

Natus Medical Incorporated / initiated 2022-11-18 / Open, Classified / root cause: sterility

FDA source

Natus Medical Incorporated began a 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 create an intracranial... on 2022-11-18. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0735-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-11-18
Posted: 2022-12-20
Recalling firm: Natus Medical Incorporated
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).
Product code: PSP Intracranial Pressure & Temperature Monitoring Kit
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 damaging the product and may render the product unusable.
Root cause tag: sterility
FDA root cause: Unknown/Undetermined by firm
Action: On 11/18/2022, the firm sent an "Amended Urgent Field Safety Notice - Recall" letter via first class mail to customers informing them that the 3M surgical drapes that are included in Natus Cranial Access Kits are being recalled by 3M Healthcare due to the liner on the adhesive component of the affected drapes are difficult to remove without damaging the product and may render the product unusable. In addition there is the potential for adhesive related skin injures. Customers are instructed to: 1. Complete the enclosed form, and return to [email protected] 2. Immediately cease use of the affected Cranial Access Kits that you have and quarantine until you receive the shipping instructions from Natus to return the product(s). Customers will receive shipping instructions from [email protected] For questions or further assistance contact Natus Technical Service Team via email [email protected]
Quantity in commerce: 249 kits
Distribution: U.S. Nationwide distribution in the states of AK, CA, CT, DC, FL, GA, IA, ID, IL, KS , MD, MI, MT, ND, NE, NJ, NV, NY, OH, OR, TX, and WA.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0735-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0735-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-28	2022-12-20

Product code PSP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)