BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated December 22, 2022

    Recall

    Recall Number
    Z-1020-2023
    Event Number
    91391
    Firm
    SunMed Holdings, LLC
    FEI Number
    1314417
    Product Code
    CAE
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    December 22, 2022
    Posted
    January 26, 2023
    Address
    2710 Northridge Dr Nw, Ste A, Grand Rapids, MI, 49544-9112

    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.

    Action

    On December 22, 2022, the firm notified affected customers through Urgent Medical Device Product Correction letters. Customers were informed that there is a discrepancy in the orogastric (OG) tube size indicated in the labeling in the instructions for use (IFU) versus the printed text on the device. Customers were provided with the correct recommended maximum OG tube/catheter sizes for each impacted Air-Q3G and Air-Q SPG model. If product has been further distributed, customers should forward the recall notice. If customers have questions about this recall notification, please contact Rob Yamashita, VP of Regulatory Affairs, at 616-259-8400, toll free at 800-433-2729, or [email protected].

    Distribution

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

    Quantity

    43,290 (Eaches)