BEUDAMED
    FDA Enforcement Class II Ongoing

    STRADIS HEALTHCARE, WECKCELL EYE SPEARS, Item Numbers: a) 9430, b) 9431

    Recall: Z-0481-2023 · Reported December 21, 2022

    Enforcement

    Recall Number
    Z-0481-2023
    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, WECKCELL EYE SPEARS, Item Numbers: a) 9430, b) 9431

    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

    a) 9430: UDI/DI (case) M75294301, UDI/DI (kit)M75294301, Serial/Lot Numbers: 22270492023 b) 9431: UDI/DI (case) M75294301, UDI/DI (kit)M75294301, Serial/Lot Numbers: 22255491774, 22255491484

    Distribution

    US nationwide distribution, and Canada.

    Quantity

    80 kits