Natus Medical Incorporated recalls The Natus Cranial Access Kit is designed to be a complete, single use and disposable accessory and instrumentation set…

Recall date

November 18, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0735-2023

FDA classification

Class II

Brand / firm

Natus Medical Incorporated

Sold / distributed

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.

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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).