BEUDAMED
    FDA Enforcement Class II Terminated

    Tourni-Cot - Universal, UDI 00855364004085, Model Number TCU, Non-pneumatic Tourniquet - Product Usage: The device is intended to be used in surgery on fingers or toes to provide a blood-less field.

    Recall: Z-0945-2021 · Reported February 10, 2021

    Enforcement

    Recall Number
    Z-0945-2021
    Event ID
    87009
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mar-Med Co
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 10, 2021
    Initiation Date
    December 28, 2020
    Classification Date
    February 2, 2021
    Termination Date
    September 14, 2023
    Address
    333 Fuller Ave Ne, Grand Rapids, MI, 49503-3630, United States

    Description

    Tourni-Cot - Universal, UDI 00855364004085, Model Number TCU, Non-pneumatic Tourniquet - Product Usage: The device is intended to be used in surgery on fingers or toes to provide a blood-less field.

    Reason

    A failure can occur if the user attempts to remove the device by partially snipping the edge and pulling on it. The device may tear into two pieces with a portion remaining in place, which can continue to constrict the vessels. This type of failure can result in digit ischemia.

    Code Info

    All lots

    Distribution

    Worldwide distribution - US Nationwide distribution and the countries of Australia, Canada, France, Germany, Greece, Italy, Japan, Netherlands, Singapore, Spain, Sweden, Switzerland, and United Kingdom.

    Quantity

    52,000