BEUDAMED
    FDA Enforcement Class II Terminated

    Non-Rebreathing Mask, Reservoir Bag, Check Valve, One Side Valve, with Tubing, Product Code 106-E, Product Code 3226MM, and Product Code 9108MM

    Recall: Z-2230-2017 · Reported June 14, 2017

    Enforcement

    Recall Number
    Z-2230-2017
    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

    Non-Rebreathing Mask, Reservoir Bag, Check Valve, One Side Valve, with Tubing, Product Code 106-E, Product Code 3226MM, and Product Code 9108MM

    Code Info

    Lot Number (Product Code 106-E), 100152, 102095, 102154, 103122, 103159, 103385, 103527, 103558, 104009, 104321, 104322, 104328, 104701, 104975, 105569, 105656, 1045675; (Product Code 3226MM) 100720, 101141; (Product Code 9108MM) 100232, 100694, 100918, 101639, 101897, 103067, 104846, 104848, 105453

    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

    N/A