BEUDAMED
    FDA Enforcement Class II Ongoing

    Ivalon Anatomical Nasal Packing with Airway Tube and String, 8.0 cm x 1.5cmx 3.0 cm- Intended To Be Used During Ophthalmic Surgical Procedures For Fluid Management Model Number: Q770410

    Recall: Z-0800-2025 · Reported January 8, 2025

    Enforcement

    Recall Number
    Z-0800-2025
    Event ID
    95909
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Carwild Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 8, 2025
    Initiation Date
    October 22, 2024
    Classification Date
    January 2, 2025
    Address
    3 State Pier Rd, New London, CT, 06320-5817, United States

    Description

    Ivalon Anatomical Nasal Packing with Airway Tube and String, 8.0 cm x 1.5cmx 3.0 cm- Intended To Be Used During Ophthalmic Surgical Procedures For Fluid Management Model Number: Q770410

    Reason

    Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product.

    Code Info

    LOT NUMBER: 24F1638

    Distribution

    IL, FL, SC. PA, AL Foreign: Netherlands

    Quantity

    140 units