BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0153-2016 · Initiated February 3, 2014

    Recall

    Recall Number
    Z-0153-2016
    Event Number
    72011
    Firm
    Innovative Sterlization Technologies LLC
    FEI Number
    3010772758
    Product Code
    KCT
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    February 3, 2014
    Posted
    October 22, 2015
    Terminated
    February 4, 2016
    Address
    7625 Paragon Rd, Ste A, Dayton, OH, 45459-4063

    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.

    Action

    The firm sent an Urgent Medical Device Recall letter dated September 14, 2015 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to fill out the attached response SASE mailer and return to or fax to the address/number identified below: Innovative Sterilization Technologies, LLC, 7625 Paragon Road, Suite A Dayton, OH 45459, 937-286-3571 (C), 937-630-4346 (F), 937-619-0138 x 202 (Office), [email protected]

    Distribution

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

    Quantity

    M2104 - 25 units; M2408 - 84 units