BEUDAMED
    FDA Enforcement Class II Terminated

    TUBING 7/8' X 10', W/WAND & TIP, 24/CS, REF 24187, QTY 24\CS, STERILE EO Intended use: The smoke evacuator and accessories are intended to evacuate the smoke created by electrosurgery, laser surgery, or power tool surgical procedures. Locations include Operating Rooms, Trauma, Endoscopy and Laparoscopy Sites.

    Recall: Z-1343-2015 · Reported April 8, 2015

    Enforcement

    Recall Number
    Z-1343-2015
    Event ID
    70721
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Microtek Medical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 8, 2015
    Initiation Date
    March 10, 2015
    Classification Date
    March 27, 2015
    Termination Date
    January 21, 2017
    Address
    602 N Lehmberg Rd, N/A, Columbus, MS, 39702-4406, United States

    Description

    TUBING 7/8' X 10', W/WAND & TIP, 24/CS, REF 24187, QTY 24\CS, STERILE EO Intended use: The smoke evacuator and accessories are intended to evacuate the smoke created by electrosurgery, laser surgery, or power tool surgical procedures. Locations include Operating Rooms, Trauma, Endoscopy and Laparoscopy Sites.

    Reason

    This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.

    Code Info

    Lot Numbers: C9336, C9355, C10005, C10015, C10050, C10065, C10126, C10189, C10214, C10224, C10265, C10320, C11122, C11154, C11270, C11315, C11335, C12051, C12089, C12101, C12121, C12130, C12201, C12268, C12304, C13002, C13018, C13043, C13070, C13093, C13155, C13190, C13228, C13281, C14052, C14147, C14174, C14195.

    Distribution

    US (nationwide) Distribution.

    Quantity

    32496 units