BEUDAMED
    FDA Enforcement Class II Terminated

    Disposable Accessory Kit, 4-Arm (Box of 5) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da Vinci Si Robotic system / Distributed by Intuitive Surgical Product Usage: Microtek Medical Equipment Drapes are intended to cover/wrap various surgical and/or nonsurgical instruments/equipment [e.g. robotic arms, microscopes, tables, x ray systems, light handles, etc]. They function as a physical barrier to prevent cross contamination between the instrument / equipment and medical staff and/or to allow the instrument/equipment to enter a hygienic area [e.g. sterile surgical field] in various clinical settings. They are typically made of flexible plastic and shaped to fit the type of instrument / equipment. They are a single use device [not to be reprocessed]

    Recall: Z-0234-2019 · Reported October 31, 2018

    Enforcement

    Recall Number
    Z-0234-2019
    Event ID
    81244
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ecolab Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 31, 2018
    Initiation Date
    September 14, 2018
    Classification Date
    October 23, 2018
    Termination Date
    February 12, 2021
    Address
    1 Ecolab Pl, N/A, Saint Paul, MN, 55102-2739, United States

    Description

    Disposable Accessory Kit, 4-Arm (Box of 5) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da Vinci Si Robotic system / Distributed by Intuitive Surgical Product Usage: Microtek Medical Equipment Drapes are intended to cover/wrap various surgical and/or nonsurgical instruments/equipment [e.g. robotic arms, microscopes, tables, x ray systems, light handles, etc]. They function as a physical barrier to prevent cross contamination between the instrument / equipment and medical staff and/or to allow the instrument/equipment to enter a hygienic area [e.g. sterile surgical field] in various clinical settings. They are typically made of flexible plastic and shaped to fit the type of instrument / equipment. They are a single use device [not to be reprocessed]

    Reason

    The pouches of certain lots of product may have wrinkles along the pouch seal that could result in a channel within the seal. Should there be a channel in the pouch seal it may result in a breach in the sterility of the product.

    Code Info

    Item 420291-03 Lot # D173147, D173177, D173517, D173437, D173487, D172937, D173407, D173417, D173317, D180117, D180177, D173477, D180087, D173187, D173137, D172987, D173217, D173067, D173497, D173447, D173427, D173287, D180167, D180027, D173577, D173077, D180097, D180157, D173627, D173607, D173467, D173567, D180197, D173257, D173637, D173457, D180267, D180257, D172997, D173547, D180317, D180237, D173227, D173537, D173507, D180107, D173617, D173267, D180247, D173197, D180057, D180187, D180347, D180337, D180377, D180037, D180307, D180437, D173017,and D180507.

    Distribution

    Worldwide - US Nationwide Distribution in the states of AK, AL, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, AND WY In the countries of Argentina, Australia, Austria, Belgium, Canada, Chile, China, Colombia, Czech Republic, Denmark, Finland, France, Germany, Guadeloupe, Iceland, Ireland, Italy, Martinique, Netherlands, Norway, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, and United Kingdom

    Quantity

    9,364 cases (46,820 eaches)