BEUDAMED
    FDA Enforcement Class II Terminated

    NICO Myriad-LX Illumination Pack: REF: NN-1000 Mvriad-LX Illumination Pack. 11ga REF: NN-1001 Mvriad-LX Illumination Pack. l3ga Intended to perform resection and removal of soft tissues and fluids under direct visualization accessories to the NICO Myriad System.

    Recall: Z-1839-2021 · Reported June 16, 2021

    Enforcement

    Recall Number
    Z-1839-2021
    Event ID
    87882
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Nico Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 16, 2021
    Initiation Date
    April 30, 2021
    Classification Date
    June 9, 2021
    Termination Date
    February 5, 2024
    Address
    250 E 96th St Ste 125, N/A, Indianapolis, IN, 46240-3872, United States

    Description

    NICO Myriad-LX Illumination Pack: REF: NN-1000 Mvriad-LX Illumination Pack. 11ga REF: NN-1001 Mvriad-LX Illumination Pack. l3ga Intended to perform resection and removal of soft tissues and fluids under direct visualization accessories to the NICO Myriad System.

    Reason

    (1) Updated IFU for the LX Illumination Packs: Warning - Avoid contact between the distal opening of the delivery sleeve and tissue/debris within the surgical.field to prevent complete occlusion. Some surgical approaches (e.g., endonasal) may increase this potential. {f unintended reduction in light output occurs and/or occlusion of the sleeve is suspected, both the delivery sleeve and the fiber should be replaced (2) Removal for the LX Light Source potential for the distal tip of the sleeve/fiber assembly potential to burn healthy tissue resulting in minor to moderate injury to the patient or end user.

    Code Info

    Lot Numbers: 37KII300 37KI1301 37LI0320 37LI0322 37AJ1438 37AJ1439 37BJ0513 37BJ0516 37CJ0203 37CJ0204 37GJ1603 37GJ1607 37110208 37IJ0209

    Distribution

    US Nationwide Distribution

    Quantity

    439 packs