BEUDAMED
    FDA Enforcement Class II Terminated

    Part #: SAM XT-C, Model: Hi-Viz Orange or Civilian

    Recall: Z-2227-2018 · Reported June 20, 2018

    Enforcement

    Recall Number
    Z-2227-2018
    Event ID
    80140
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    The Seaberg Company Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 20, 2018
    Initiation Date
    May 2, 2018
    Classification Date
    June 14, 2018
    Termination Date
    July 1, 2020
    Address
    27350 SW 95th Ave Ste 3038, N/A, Wilsonville, OR, 97070-7709, United States

    Description

    Part #: SAM XT-C, Model: Hi-Viz Orange or Civilian

    Reason

    Based on internal testing, results indicated a possible failure of the stitches securing the buckle to the nylon belt could occur, posing a potential risk when used on a human patient to stop arterial blood flow. There is a remote chance that a serious injury and/or death could occur as a result of the failure of the device.

    Code Info

    Lot #: XT1711, XT1712, XT1715, XT1716, XT1717, XT1719, XT1722, XT1723, XT1724, XT1726, XT1730, XT1731, XT1732, XT1734, XT1735, XT1736, XT1737, XT1738, XT1741, XT1744, XT1745, XT1748, XT1750, XT1751, XT1803, XT1804, XT1806, XT1807, XT1808

    Distribution

    USA: CA, MD, OH, FL, ID, CO, CT, OR, AZ, IL, ME, MO, NY, SC, MI, AR, MT, CT, WA, TX, KY, NC, NJ, PA OUS: Australia, Canada, China, Columbia, Costa Rica, Europe (EU), Hong Kong, Iceland, India, Iraq, Israel, Japan, Kenya, Korea, Lebanon, Malaysia, Russia, Saudi Arabia, Singapore, South Africa, Thailand, UAE

    Quantity

    N/A