BEUDAMED
    FDA Enforcement Class I Ongoing

    Auxiliary Common Gas Outlet (ACGO) conversion/install kits sold under product names CONV KIT SCGO TO ACGO and ACGO ASSY FIELD INSTL. These kits are not affected specifically, however are included due to being purchased with or later used to convert to ACGO.

    Recall: Z-0084-2025 · Reported October 30, 2024

    Enforcement

    Recall Number
    Z-0084-2025
    Event ID
    95045
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Datex-Ohmeda, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 30, 2024
    Initiation Date
    July 12, 2024
    Classification Date
    October 18, 2024
    Address
    3030 Ohmeda Dr, N/A, Madison, WI, 53718-6704, United States

    Description

    Auxiliary Common Gas Outlet (ACGO) conversion/install kits sold under product names CONV KIT SCGO TO ACGO and ACGO ASSY FIELD INSTL. These kits are not affected specifically, however are included due to being purchased with or later used to convert to ACGO.

    Reason

    Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.

    Code Info

    No GTIN. Spare Part Numbers: 1009-8249-000, 1011-8071-000. Not model or lot specific. All devices of the indicated products configured with the AGCO option are potentially affected.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Aland Islands, ALBANIA, Algeria, Argentina, Australia, Austria, Azerbaijan, BAHAMAS, Bahrain, Bangladesh, BARBADOS, BELARUS, Belgium, Benin, Bermuda, Bolivia, BONAIRE, Bosnia and Herzegovina, Brazil, Brunei, Bulgaria, Cambodia, Cameroon, Canada, Chile, CHINA, Colombia, Costa Rica, Croatia, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, ETHIOPIA, Falkland Islands, Finland, France, French Polynesia, Gabon, Georgia, Germany, Ghana, Gilbrator, Greece, Guadeloupe, Guatemala, Guyana, Honduras, Hong Kong, Hungary, ICELAND, India, Indonesia, Iran, IRAQ, Ireland, Israel, Italy, Jamaica, JAPAN, Jordan, Kazakhstan, KENYA, Korea (Republic Of), Korea, Republic of, Kuwait, Laos, LATVIA, Lebanon, Libya, LITHUANIA, Macedonia, Malaysia, Maldives, Malta, MAURITIUS, Mexico, Moldova, Montenegro, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, North Macedonia, Norway, Oman, PAKISTAN, Palestine, State of, Panama, Paraguay, Peru, Philippines, Poland, Portugal, PUERTO RICO, Qatar, REUNION, ROMANIA, Russia, San Marino, Saudi Arabia, Senegal, Serbia, SINGAPORE, Slovakia, Slovenia, South Africa, Spain, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, THAILAND, Trinidad and Tobago, Tunisia, Turkey, T¿rkiye, Uganda, UKRAINE, United Arab Emirates, United Kingdom, Uruguay, UZBEKISTAN, Venezuela, Vietnam, Yemen.

    Quantity

    649 units