BEUDAMED
    FDA Enforcement Class II Terminated

    OneTray Sealed Sterilization Containers Product Usage: A rigid sterilization container used to steam sterilize medical devices

    Recall: Z-0153-2016 · Reported October 28, 2015

    Enforcement

    Recall Number
    Z-0153-2016
    Event ID
    72011
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Innovative Sterlization Technologies LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    October 28, 2015
    Initiation Date
    February 3, 2014
    Classification Date
    October 21, 2015
    Termination Date
    February 4, 2016
    Address
    7625 Paragon Rd Ste A, N/A, Dayton, OH, 45459-4063, United States

    Description

    OneTray Sealed Sterilization Containers Product Usage: A rigid sterilization container used to steam sterilize medical devices

    Reason

    The wrong sterilization time was on the label. The label lists Steam Gravity 10 - 34 minutes at 270 degrees F instead of Steam Gravity 17 - 34 minutes at 270 degrees F.

    Code Info

    M2104 Lot # 044305, 044379, 044380 & 044418. M2408 Lot # 044296, 022304, 044381, 044420, 044421 & 044422.

    Distribution

    US Nationwide Distribution in the states of IL, IN, LA, OH, PA, TX & WV.

    Quantity

    M2104 - 25 units; M2408 - 84 units