BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-0279-2023 · Initiated October 27, 2022

    Recall

    Recall Number
    Z-0279-2023
    Event Number
    91129
    Firm
    Southmedic, Inc.
    FEI Number
    3001717360
    Product Code
    GES
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    October 27, 2022
    Posted
    November 23, 2022
    Address
    50 Alliance Blvd, Barrie 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.

    Action

    Southmedic sent and URGENT: MEDICAL DEVICE RECALL notice its consignees on 10/28/2022 by email. The notice explained the issue and requested the product be destroyed. The response forms indicate that the direct consignee notify its customers

    Distribution

    US Nationwide distribution in the state of IL.

    Quantity

    450 units