BEUDAMED
    FDA Enforcement Class II Ongoing

    AirQ3 Self Pressurizing ILA with Automatic Cuff Inflation and GA Size REF Number 0.0 60005 0.5 60055 1.0 60105 1.5 60155 2.0 60205 3.0 60305 4.0 60405

    Recall: Z-1020-2023 · Reported February 1, 2023

    Enforcement

    Recall Number
    Z-1020-2023
    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

    AirQ3 Self Pressurizing ILA with Automatic Cuff Inflation and GA Size REF Number 0.0 60005 0.5 60055 1.0 60105 1.5 60155 2.0 60205 3.0 60305 4.0 60405

    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 60005 Each: 00814954020263 Box: 10814954020260 Case: 20814954020267 0.5 60055 Each: 00814954020270 Box: 10814954020277 Case: 20814954020274 1.0 60105 Each: 00814954020287 Box: 10814954021083 Case: 20814954020281 1.5 60155 Each: 00814954020294 Box: 10814954021090 Case: 20814954020298 2.0 60205 Each: 00814954020300 Box: 10814954021106 Case: 20814954020304 3.0 60305 Each: 00814954020317 Box: 10814954021113 Case: 20814954020311 4.0 60405 Each: 00814954020324 Box: 10814954021120 Case: 20814954020328

    Distribution

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

    Quantity

    43,290 (Eaches)