BEUDAMED
    FDA Enforcement Class II Terminated

    FDI FORT DEFIANCE INDUSTRIES P2131 AUTOMATED FIELD STEAM STERILIZER, NSN: 6530-01-641-4641 Product Usage: The Fort Defiance Industries Automated Field Steam Sterilizer Model P2131 is designed for sterilization of porous and non-porous, heat- and moisture-stable materials (e.g., surgical instruments and textiles) used in healthcare facilities. The P2131 sterilizer is a transportable device designed for use in a variety of austere environments.

    Recall: Z-2411-2018 · Reported July 18, 2018

    Enforcement

    Recall Number
    Z-2411-2018
    Event ID
    80293
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Fort Defiance Industries, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 18, 2018
    Initiation Date
    May 24, 2018
    Classification Date
    July 10, 2018
    Termination Date
    June 27, 2023
    Address
    2411 Maremont Pkwy, Loudon, TN, 37774-1066, United States

    Description

    FDI FORT DEFIANCE INDUSTRIES P2131 AUTOMATED FIELD STEAM STERILIZER, NSN: 6530-01-641-4641 Product Usage: The Fort Defiance Industries Automated Field Steam Sterilizer Model P2131 is designed for sterilization of porous and non-porous, heat- and moisture-stable materials (e.g., surgical instruments and textiles) used in healthcare facilities. The P2131 sterilizer is a transportable device designed for use in a variety of austere environments.

    Reason

    During long-term storage (i.e. military depot), the interaction of stagnant water and dissimilar metals in the plumbing of the P2131 device produces deposits in the water system that can potentially interfere with the rear sight gauge and / or the water liquid level switch.

    Code Info

    Serial Numbers: AFS-0001 through AFS-0199

    Distribution

    US Nationwide Distribution in the states of PA. VA. TX

    Quantity

    199 units