Home / Recalls / Medical Devices
Natus Medical Incorporated recalls The Natus Cranial Access Kit is designed to be a complete, single use and disposable accessory and instrumentation set t
Recalled December 28, 2022 · FDA recall Z-0735-2023 · Natus Medical Incorporated
Hazard
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 Class II
Units
249 kits
Sold at
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.
Description
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.
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).
Manufacturer(s)
Natus Medical Incorporated
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →