BEUDAMED
    FDA Enforcement Class II Ongoing

    Southmedic SAFETY CARTRIDGE WITH SOUTHMEDIC PLUS SURGICAL BLADE, REF 73-8020, STERILE EO

    Recall: Z-0279-2023 · Reported November 30, 2022

    Enforcement

    Recall Number
    Z-0279-2023
    Event ID
    91129
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Southmedic, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 30, 2022
    Initiation Date
    October 27, 2022
    Classification Date
    November 23, 2022
    Address
    50 Alliance Blvd, N/A, Barrie, N/A, N/A, Canada

    Description

    Southmedic SAFETY CARTRIDGE WITH SOUTHMEDIC PLUS SURGICAL BLADE, REF 73-8020, STERILE EO

    Reason

    Upon review of its batch record, Southmedic identified that lot # W92761 was not sent out for sterilization, and was instead transferred directly to distribution where it was sold and distributed to customers as non-sterile product labelled as sterile.

    Code Info

    GTIN 620974002628, Lot number: W92761

    Distribution

    US Nationwide distribution in the state of IL.

    Quantity

    450 units