BEUDAMED
    FDA Enforcement Class II Ongoing

    STRADIS HEALTHCARE, Angioplasty, Item No.682-1937,

    Recall: Z-0544-2023 · Reported December 21, 2022

    Enforcement

    Recall Number
    Z-0544-2023
    Event ID
    91124
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Stradis Medical, LLC dba Stradis Healthcare
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 21, 2022
    Initiation Date
    November 2, 2022
    Classification Date
    December 14, 2022
    Address
    3025 Northwoods Pkwy, N/A, Peachtree Corners, GA, 30071-1524, United States

    Description

    STRADIS HEALTHCARE, Angioplasty, Item No.682-1937,

    Reason

    Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.

    Code Info

    UDI/DI (case) M75268219371, UDI/DI (kit)M75268219370, Serial/Lot Numbers: 22237490509

    Distribution

    US nationwide distribution, and Canada.

    Quantity

    100 units