BEUDAMED
    FDA Enforcement Class II Terminated

    Ref: NT821731C, Natus EDS 3 CSF External Drainage System - Product Usage: indicated for draining cerebrospinal fluid (CFS) from the cerebral ventricles or the lumbar subarachnoid space as a means of reducing intracranial pressure and CSF volume when the insertion of a permanent, internal shunt is not indicated.

    Recall: Z-1143-2021 · Reported March 3, 2021

    Enforcement

    Recall Number
    Z-1143-2021
    Event ID
    87175
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Natus Manufacturing Limited
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 3, 2021
    Initiation Date
    January 12, 2021
    Classification Date
    February 22, 2021
    Termination Date
    November 8, 2022
    Address
    Ida Business Park, Glenbrack Road, Galway, N/A, N/A, Ireland

    Description

    Ref: NT821731C, Natus EDS 3 CSF External Drainage System - Product Usage: indicated for draining cerebrospinal fluid (CFS) from the cerebral ventricles or the lumbar subarachnoid space as a means of reducing intracranial pressure and CSF volume when the insertion of a permanent, internal shunt is not indicated.

    Reason

    The external drainage system failed to meet Pyrogen test requirements for devices contacting cerebrospinal fluid of 2.15 endotoxins.

    Code Info

    Lot # 118000422298

    Distribution

    US Nationwide distribution in the state of NY.

    Quantity

    7 units