BEUDAMED
    FDA Recall Open, Classified

    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).

    Recall: Z-0735-2023 · Initiated November 18, 2022

    Recall

    Recall Number
    Z-0735-2023
    Event Number
    91193
    Firm
    Natus Medical Incorporated
    FEI Number
    2023988
    Product Code
    PSP
    Status
    Open, Classified
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    November 18, 2022
    Posted
    December 20, 2022
    Address
    5955 Pacific Center Blvd, San Diego, CA, 92121-4309

    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

    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.

    Action

    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]

    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.

    Quantity

    249 kits