The Natus Cranial Access Kit is designed to be a complete, single use and disposable accessory and instrumentation set t
Summary
The FDA issued a Class II for The Natus Cranial Access Kit is designed to be a complete, single use and dispos by Natus Medical Incorporated. Reason: Due to Cranial Access Kits containing recalled sterile surgical drapes. The sterile surgical drapes are being recalled due to the liner on the adhesi.
Details
Source
Device Recall
External ID
Z-0735-2023
Action Date
2022-12-28
Status
Ongoing
Category
device
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).
Lot/Code Info: 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
Quantity Affected: 249 kits
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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-11-18
Company
San Diego, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 404 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Natus Medical Incorporated has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Natus Medical Incorporated) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Natus Medical Incorporated have FDA actions?
Natus Medical Incorporated has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0735-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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