BEUDAMED
    FDA Enforcement Class II Ongoing

    6.5 IN (17 cm) APPX 0.78 ml, EXT SET w/Clave CLEAR, Clave 4-WAY Stopcock, Spiros, RED CAP. Accessory for intravascular administration set.

    Recall: Z-1723-2022 · Reported September 21, 2022

    Enforcement

    Recall Number
    Z-1723-2022
    Event ID
    90726
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    ICU Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 21, 2022
    Initiation Date
    August 1, 2022
    Classification Date
    September 9, 2022
    Address
    951 Calle Amanecer, San Clemente, CA, 92673-6212, United States

    Description

    6.5 IN (17 cm) APPX 0.78 ml, EXT SET w/Clave CLEAR, Clave 4-WAY Stopcock, Spiros, RED CAP. Accessory for intravascular administration set.

    Reason

    Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.

    Code Info

    Product Number: CH3771 UDI Code: 0110887709098678172702013050105782919 Lot Numbers: 5782919

    Distribution

    U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. O.U.S.: Austria, Bahrain, Belgium, Canada, Colombia, Estonia, France, Germany, Ireland, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, Peru, Poland, Saudi Arabia, Slovakia, Slovenia, Spain, Sweden, Thailand, Turkey, United Arab Emirates, United Kingdom, and Vietnam. O.U.S.

    Quantity

    Total of all affected units = 5,795,989 units