BEUDAMED
    FDA Recall Terminated

    Part #: SAM XT-C, Model: Hi-Viz Blue

    Recall: Z-2228-2018 · Initiated May 2, 2018

    Recall

    Recall Number
    Z-2228-2018
    Event Number
    80140
    Firm
    The Seaberg Company Inc
    FEI Number
    3023316
    Product Code
    GAX
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    May 2, 2018
    Terminated
    July 1, 2020
    Address
    27350 SW 95th Ave, Ste 3038, Wilsonville, OR, 97070-7709

    Description

    Part #: SAM XT-C, Model: Hi-Viz Blue

    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.

    Action

    On 05/02/2018, the firm posted a press release notifying customers of a recall of all unused SAM XT Extremity Tourniquets (SAM XT) due to a possible failure of the stitches securing the buckle to the nylon belt that could pose a potential risk when used on a human patient to stop arterial blood flow. On 05/03/2018, recall notification forms were mailed to customers via overnight mail service.

    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