BEUDAMED
    FDA Enforcement Class II Ongoing

    Air-Q3 AirQ3 Standard ILA with Manual Cuff Inflation and GA Size REF Number 0.0 50005 0.5 50055 1.0 50105 1.5 50155 2.0 50205 3.0 50305 4.0 50405

    Recall: Z-1019-2023 · Reported February 1, 2023

    Enforcement

    Recall Number
    Z-1019-2023
    Event ID
    91391
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    SunMed Holdings, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 1, 2023
    Initiation Date
    December 22, 2022
    Classification Date
    January 26, 2023
    Address
    2710 Northridge Dr Nw Ste A, N/A, Grand Rapids, MI, 49544-9112, United States

    Description

    Air-Q3 AirQ3 Standard ILA with Manual Cuff Inflation and GA Size REF Number 0.0 50005 0.5 50055 1.0 50105 1.5 50155 2.0 50205 3.0 50305 4.0 50405

    Reason

    There is an orogastric (OG) tube size discrepancy between the labeling in the IFU and the printed text on the device. If the clinician is unable to pass a gastric catheter through one of the channels, the clinician may use a smaller-diameter gastric catheter.

    Code Info

    ALL LOTS Size REF UDI/DI 0.0 50005 Each: 00814954020188 Box: 10814954020185 Case: 20814954020182 0.5 50055 Each: 00814954020195 Box: 10814954020192 Case: 20814954020199 1.0 50105 Each: 00814954020201 Box: 10814954021007 Case: 20814954020205 1.5 50155 Each: 00814954020218 Box: 10814954021014 Case: 20814954020212 2.0 50205 Each: 00814954020225 Box: 10814954021021 Case: 20814954020229 3.0 50305 Each: 00814954020232 Box: 10814954021038 Case: 20814954020236 4.0 50405 Each: 00814954020249 Box: 10814954021045 Case: 20814954020243

    Distribution

    US Nationwide distribution in the states of AL, CA, FL, MI, OH, TN, TX, WA.

    Quantity

    43,290 (Eaches)