Recall Z-0735-2023— Natus Medical Incorporated
Class II · Ongoing
Class II FDA medical device recall by Natus Medical Incorporated, initiated 2022-11-18. FDA's recall record names no specific 510(k) clearance for this event. 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).. Reason: 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..
- Recalling firm
- Natus Medical Incorporated
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-11-18
- Firm location
- San Diego, CA, United States
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).
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.