BEUDAMED
    FDA Enforcement Class II Ongoing

    Getinge CM320-2 CHAMBER WU Series Washer Disinfector- For Use as a multi-chamber washer-disinfector for the washing, disinfecting and drying surgical instruments, etc. Model: CM320 WU

    Recall: Z-1248-2022 · Reported June 15, 2022

    Enforcement

    Recall Number
    Z-1248-2022
    Event ID
    90146
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Getinge Usa Sales Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 15, 2022
    Initiation Date
    April 13, 2022
    Classification Date
    June 8, 2022
    Address
    1 Geoffrey Way, Wayne, NJ, 07470-2035, United States

    Description

    Getinge CM320-2 CHAMBER WU Series Washer Disinfector- For Use as a multi-chamber washer-disinfector for the washing, disinfecting and drying surgical instruments, etc. Model: CM320 WU

    Reason

    Verification of installation not documented or may be incomplete, could result in harm to the user such as skin burns, smoke inhalation, electric shock, or a crush or pinch injury or slip and fall injury. May lead to a patient procedural delay and/or infection

    Code Info

    UDI-DI: 07340153700185 Serial Numbers: W50034570 WAA070170 WAA070618 WAA081312

    Distribution

    US Nationwide distribution in the states of MD, MN, ND, NE, NY, PA, VA.

    Quantity

    4 units