BEUDAMED
    FDA Enforcement Class II Terminated

    Oxygen Masks, Elongated (under chin), Adult Med Conc., No Tubing, Product Code 104-E;

    Recall: Z-2228-2017 · Reported June 14, 2017

    Enforcement

    Recall Number
    Z-2228-2017
    Event ID
    77282
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ConvaTec, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 14, 2017
    Initiation Date
    May 10, 2017
    Classification Date
    June 2, 2017
    Termination Date
    August 27, 2021
    Address
    7900 Triad Center Dr Ste 400, N/A, Greensboro, NC, 27409-9076, United States

    Description

    Oxygen Masks, Elongated (under chin), Adult Med Conc., No Tubing, Product Code 104-E;

    Reason

    Reports of tubing detaching from oxygen masks either prior to use (in packaging) or during use were made by different end users and for different batches. The failures were caused by an improper solvent bond between the oxygen tubing and the oxygen mask connector. While the defect affects less than 2% of recalled product, there is a potential for harm when oxygen supply to the user is disrupted.

    Code Info

    Lot Number 102153, 102339, 102941, 103176, 103453, 103718, 103919, 104471, 105034, 105282, 105427, 105567, 105996, 106960, 108658, 112024, 112530

    Distribution

    CA, CT, FL, GA, IL, MO, NJ, NY, NC, OH, PA, RI, VA , Puerto Rico, Australia, Belgium, Canada, Columbia, Czech, Denmark, Finland, France, Germany, Greece, Israel, Italy, Japan, Jordan, Malaysia, Malta, Netherlands, Norway, Rwanda, Saudi Arabia, Sweden, Switzerland, United Kingdom, and Vietnam

    Quantity

    816,709