BEUDAMED
    FDA Recall Open, Classified

    CareFusion V.Mueller GENESIS QTR-LENGTH CONTAINER 12 X 8" (30.3X20.3CM) 4" (10.2CM) DEEP STERRAD COMPATIBLE, REF CD0-4ST

    Recall: Z-0204-2023 · Initiated September 26, 2022

    Recall

    Recall Number
    Z-0204-2023
    Event Number
    90958
    Firm
    Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845
    FEI Number
    3008002452
    Product Code
    KCT
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    September 26, 2022
    Posted
    November 11, 2022

    Description

    CareFusion V.Mueller GENESIS QTR-LENGTH CONTAINER 12 X 8" (30.3X20.3CM) 4" (10.2CM) DEEP STERRAD COMPATIBLE, REF CD0-4ST

    Reason

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

    Action

    The firm disseminated URGENT MEDICAL DEVICE RECALL noticed on 10/04/2022 by Fed Ex 2-Day. The notices explained the issue and the hazard and requested the following: "1. Please check all inventory locations within your institution for the Product and immediately dispose of all affected Product remaining in your possession in accordance with your local facility s process. Please note the following materials for each component and dispose of them accordingly: Component: Container (bottoms, lids, retention plates), Material: Anodized aluminum 5000 and 1100 series, stainless steel 300 series Component: Gasket and handle grips, Material: Silicone Component: Baskets (if applicable), Material: 304 Stainless Steel 2. Share this notification with all users within your facility network of the Product to ensure they are also aware of this field action. 3. If you purchased this Product from a distributor, contact your distributor for further instructions and credit resolution. 4. Complete the attached Customer Response Form and return it to the BD contact noted on the form whether or not you have any of the Product so that BD may acknowledge your receipt of this notification per FDA requirements. 5. Indicate on the response form the quantity of Product identified at your facility and confirm that this Product inventory was disposed of. 6. Please contact your BD representative if you require assistance with this process or you may also contact the number below for further assistance."

    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

    1143 units