BEUDAMED
    FDA Enforcement Class II Terminated

    Southmedic Sterile Disposable Scalpel Rx only Scalpels are intended to be used in various medical procedures for preparation, scraping and/or cutting of tissue.

    Recall: Z-1892-2018 · Reported May 23, 2018

    Enforcement

    Recall Number
    Z-1892-2018
    Event ID
    80074
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Southmedic, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 23, 2018
    Initiation Date
    November 6, 2017
    Classification Date
    May 17, 2018
    Termination Date
    April 2, 2020
    Address
    50 Alliance Blvd, Barrie, N/A, Canada

    Description

    Southmedic Sterile Disposable Scalpel Rx only Scalpels are intended to be used in various medical procedures for preparation, scraping and/or cutting of tissue.

    Reason

    Scalpels lot contains non-sterile products labeled as sterile.

    Code Info

    Part Number 73-0115 Lot Number 092517

    Distribution

    US Distribution to the states of : IA, IL, NE, NY and TX

    Quantity

    3,300 scalpels