BEUDAMED
    FDA Enforcement Class II Ongoing

    REF CH3397 Oncology Kit w/Spiros¿, Red Cap, Bag Spike w/Clave Additive Port LOT 5118610 - Product Usage: for use in the preparation and patient administration of cytotoxic medications.

    Recall: Z-1565-2021 · Reported May 19, 2021

    Enforcement

    Recall Number
    Z-1565-2021
    Event ID
    87703
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    ICU Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 19, 2021
    Initiation Date
    March 16, 2021
    Classification Date
    May 13, 2021
    Address
    951 Calle Amanecer, San Clemente, CA, 92673-6212, United States

    Description

    REF CH3397 Oncology Kit w/Spiros¿, Red Cap, Bag Spike w/Clave Additive Port LOT 5118610 - Product Usage: for use in the preparation and patient administration of cytotoxic medications.

    Reason

    Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.

    Code Info

    REF: CH3397 UDI: (01) 1 0840619 07367 8 (17) 251201 (30) 50 (10) 5118610 Lot Number: 5118610

    Distribution

    Worldwide distribution - U.S. Nationwide distribution in the states of AK, AL, AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA and WA. The countries of Belgium, Canada, France, Italy, South Africa, Spain, United Kingdom.