BEUDAMED
    FDA Recall Open, Classified

    Curaplex Nasal Intubation Kit with 6mm Endotrol Tube-To perform a nasal intubation to establish an airway in an emergency. Item Number: 023060S

    Recall: Z-1307-2024 · Initiated February 12, 2024

    Recall

    Recall Number
    Z-1307-2024
    Event Number
    94116
    Firm
    Sarnova HC, Llc
    FEI Number
    3014680755
    Product Code
    LNZ
    Status
    Open, Classified
    Root Cause
    Component design/selection
    Initiated
    February 12, 2024
    Posted
    March 19, 2024
    Address
    5000 Tuttle Crossing Blvd, Dublin, OH, 43016-1534

    Description

    Curaplex Nasal Intubation Kit with 6mm Endotrol Tube-To perform a nasal intubation to establish an airway in an emergency. Item Number: 023060S

    Reason

    Endotracheal Tube Holder included in certain kits is not compatible with a nasal intubation procedure, leaving practitioners without the necessary means to secure the inserted endotracheal tube.

    Action

    Bound Tree issued URGENT NOTICE OF RECALL letters on February 12, 2024 via USPS Letter to Medical Inventory Controls/Supplies Coordinator/Buyer. Letter states reason for recall, health risk and actin to take: Should you determine your inventory contains product covered by this recall, please immediately quarantine your affected product and contact Bound Tree Medical Customer Care at 800.533.0523 to arrange for a return of the product in exchange for a credit

    Distribution

    US Nationwide distribution.

    Quantity

    540 kits