BEUDAMED
    FDA Enforcement Class II Ongoing

    CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 8" (20.3CM) DEEP STERRAD COMPATIBLE, REF CD2-8ST

    Recall: Z-0211-2023 · Reported November 23, 2022

    Enforcement

    Recall Number
    Z-0211-2023
    Event ID
    90958
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Carefusion 2200 Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 23, 2022
    Initiation Date
    September 26, 2022
    Classification Date
    November 11, 2022
    Address
    75 N Fairway Dr, N/A, Vernon Hills, IL, 60061-1845, United States

    Description

    CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 8" (20.3CM) DEEP STERRAD COMPATIBLE, REF CD2-8ST

    Reason

    Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.

    Code Info

    UDI/DI (01) 10885403019203, ALL LOTS

    Distribution

    US and Australia, Bahrain, Canada, Denmark, Hong Kong, Italy, Japan, Malaysia, Mexico, Norway, Philippines, Saudi Arabia, Singapore, South Africa, Sweden, Thailand, UK, United Arab Emirates

    Quantity

    16 units