BEUDAMED
    FDA Recall Open, Classified

    P2131 Automated Field Steam Sterilizer NSN: 6530-01-641-4641

    Recall: Z-0121-2022 · Initiated August 19, 2021

    Recall

    Recall Number
    Z-0121-2022
    Event Number
    88628
    Firm
    Fort Defiance Industries, LLC
    FEI Number
    3011421558
    Product Code
    FLE
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    August 19, 2021
    Address
    2411 Maremont Pkwy, Loudon, TN, 37774-1066

    Description

    P2131 Automated Field Steam Sterilizer NSN: 6530-01-641-4641

    Reason

    The rear heater plate and cover assembly that contains the electrical wiring for the heaters does not have sufficient bonding to ground.

    Action

    A Recall notification letter titled, "MEDICAL DEVICE ADVISORY NOTICE" was sent to consignees on 08/19/2021 via a email. The notice provides instructions regarding continued use of the device until FDI provides a protective cover for the rear heater plate and cover assembly. It mentions, "THE OPERATOR SHOULD NOT TOUCH THE REAR HEATER PLATE AND COVER ASSEMBLY OF THE DEVICE WHILE THE DEVICE IS IN USE OR POWERED ON. IF ACCESS TO THE REAR OF THE DEVICE IS REQUIRED, PLEASE TURN THE POWER OF THE UNIT OFF USING THE FRONT PANEL SWITCH OR DISCONNECT INCOMING POWER TO THE DEVICE. DO NOT ATTEMPT TO MODIFY THE DEVICE TO CHANGE THE ELECTRICAL GROUND CONDITION OF THE HEATER PLATE AND COVER ASSEMBLY AS THIS WILL IMPACT DEVICE PERFORMANCE."

    Distribution

    Distributed nationwide to PA, MD, TX, NJ, OH, TN, UT, VA and internationally to Canada.

    Quantity

    380 devices