BEUDAMED
    FDA Recall Open, Classified

    Aeris Balloon Dilation Catheter

    Recall: Z-2148-2023 · Initiated May 16, 2023

    Recall

    Recall Number
    Z-2148-2023
    Event Number
    92558
    Firm
    Bryan Medical Inc
    FEI Number
    3005803389
    Product Code
    KTI
    Status
    Open, Classified
    Root Cause
    Error in labeling
    Initiated
    May 16, 2023
    Posted
    July 17, 2023
    Address
    6100 Wooster Pike, Cincinnati, OH, 45227-4209

    Description

    Aeris Balloon Dilation Catheter

    Reason

    Devices were mislabeled.

    Action

    Customers were emailed a recall notification dated 5/16/2023 requesting the return of affected devices. Customers were asked to quarantine all affected devices, complete the attached Recall Notification Confirmation Form, and return the form to the individuals identified in the notice.

    Distribution

    US Nationwide distribution in the states of GA, NY, & PA.

    Quantity

    5 units