BEUDAMED
    FDA Enforcement Class II Terminated

    Skytron Integrity 270 Steam Sterilizer and Skytron Integrity 270VP Steam Product Usage: The SKYTRON Integrity 270 Steam Sterilizer for use in health care facilities. The Integrity Sterilizer incorporates high-pressure steam to sterilize nonporous or porous items and materials used in the health care industry

    Recall: Z-1779-2019 · Reported June 19, 2019

    Enforcement

    Recall Number
    Z-1779-2019
    Event ID
    82650
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Skytron, Div. The KMW Group, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 19, 2019
    Initiation Date
    April 18, 2019
    Classification Date
    June 13, 2019
    Termination Date
    April 17, 2020
    Address
    5085 Corporate Exchange Blvd SE, N/A, Grand Rapids, MI, 49512-5515, United States

    Description

    Skytron Integrity 270 Steam Sterilizer and Skytron Integrity 270VP Steam Product Usage: The SKYTRON Integrity 270 Steam Sterilizer for use in health care facilities. The Integrity Sterilizer incorporates high-pressure steam to sterilize nonporous or porous items and materials used in the health care industry

    Reason

    Weld attaching the air heater assembly to the main sterilizer unit has shown signs of fatigue/failure

    Code Info

    Serial Numbers: 14092619, 14092620, 14102621, 17123520, 18113521

    Distribution

    US Nationwide Distribution - AK, IA, MS

    Quantity

    5 units