BEUDAMED
    FDA Enforcement Class II Ongoing

    Stradis Healthcare TCTR Convenience Kit. Manufactured by Stradis Healthcare.

    Recall: Z-0944-2023 · Reported January 18, 2023

    Enforcement

    Recall Number
    Z-0944-2023
    Event ID
    91350
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Stradis Healthcare
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 18, 2023
    Initiation Date
    December 15, 2022
    Classification Date
    January 11, 2023
    Address
    3600 Burwood Dr, Waukegan, IL, 60085-8399, United States

    Description

    Stradis Healthcare TCTR Convenience Kit. Manufactured by Stradis Healthcare.

    Reason

    Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

    Code Info

    Assembly Number TCTR01, UDI-DI: M752TCTR011, Lot Numbers: 222014334

    Distribution

    US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.

    Quantity

    80 units