BEUDAMED
    FDA Enforcement Class II Terminated

    Intersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-50kg Model Number: 8003000

    Recall: Z-0096-2023 · Reported October 26, 2022

    Enforcement

    Recall Number
    Z-0096-2023
    Event ID
    90855
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Intersurgical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    October 26, 2022
    Initiation Date
    August 29, 2022
    Classification Date
    October 17, 2022
    Termination Date
    October 19, 2023
    Address
    6757 Kinne St, N/A, East Syracuse, NY, 13057-1215, United States

    Description

    Intersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-50kg Model Number: 8003000

    Reason

    Printing error on the device, size 3 Solus Standard laryngeal mask airway has been incorrectly marked with size 4 information (includes the number 4 as a size identifier, patient weight and maximum inflation volume on the airway tube and the marking #4 on the inflation line pilot balloon) may pose health risk to the patient

    Code Info

    UDI-DISingle unit: 5030267073511 UDI-DICase: 05030267046959 Lot code: 32204071

    Distribution

    OH, TN, TX

    Quantity

    340 pieces