The Natus Cranial Access Kit is designed to be a complete… recallZ-0735-2023 · Natus Medical Incorporated · initiated Nov 18, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Natus Medical Incorporated or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Unknown/Undetermined by firm
What the company is doing
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]
Recall details
- Recall number
- Z-0735-2023
- Status
- Open, Classified
- Initiated by the company
- Nov 18, 2022
- Posted by the FDA
- Dec 20, 2022
- Recalling firm
- Natus Medical Incorporated
- Quantity
- 249 kits
- Product code
- PSP
- 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 description
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).
Code information (models, lots, serial numbers)
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
Devices named in this recall
3 devices in the FDA device registry whose identifier appears in the recall's code information.
- Natus® HITH1Natus Medical Incorporated · Endoscopic Ventricular Catheter Placement Kit1 recall0 reports
- Natus® HITHNDRZRNatus Medical Incorporated · Endoscopic Ventricular Catheter Placement Kit1 recall0 reports
- Natus® HITHLTNatus Medical Incorporated · Endoscopic Ventricular Catheter Placement Kit1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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