BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-0121-2022 · Reported October 27, 2021

    Enforcement

    Recall Number
    Z-0121-2022
    Event ID
    88628
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Fort Defiance Industries, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 27, 2021
    Initiation Date
    August 19, 2021
    Classification Date
    October 15, 2021
    Address
    2411 Maremont Pkwy, N/A, Loudon, TN, 37774-1066, United States

    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.

    Code Info

    Model number: P2131; NSN: 6530-01-641-4641; Serial Numbers AFS-0001 through AFS-0386. Note: AFS-0297 was not manufactured.

    Distribution

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

    Quantity

    380 devices