BEUDAMED
    FDA Enforcement Class II Terminated

    SAM Junctional Tourniquet (SJT) Auxiliary, Model SJT 102 and SJT 112. The SJT models specific intended uses are to control difficult bleeds in the inguinal area and to immobilize a pelvic fracture.

    Recall: Z-0133-2015 · Reported November 5, 2014

    Enforcement

    Recall Number
    Z-0133-2015
    Event ID
    69395
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sam Medical Products
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Press Release
    Report Date
    November 5, 2014
    Initiation Date
    August 14, 2014
    Classification Date
    October 24, 2014
    Termination Date
    July 21, 2015
    Address
    27350 SW 95th Ave Ste 3038, N/A, Wilsonville, OR, 97070-7709, United States

    Description

    SAM Junctional Tourniquet (SJT) Auxiliary, Model SJT 102 and SJT 112. The SJT models specific intended uses are to control difficult bleeds in the inguinal area and to immobilize a pelvic fracture.

    Reason

    SAM Junctional Tourniquet (SJT) Auxiliary strap, model SJT 102 and SJT 112, is recalled because the snap hook on auxiliary strap broke during training demonstration.

    Code Info

    SJT 112 Lot number (represented as date codes): 6/5/14; SJT 102 Lot numbers (represented as date codes): 3/29/2013, 5/15/2013, 6/11/2013, 7/16/2013, 8/27/2013, 9/3/2013, 9/10/2013, 11/4/2013, 12/9/2013, 12/11/2013, 1/10/2014, 1/30/2014, 2/25/2014, 3/4/2014, 3/5/2014, 3/19/2014, 3/21/2014, 3/24/2014, 3/31/2014, 4/1/2014, 4/2/2014, 4/4/2014, 4/7/2014, 4/9/2014, 4/11/2014, 4/22/2014, 4/28/2014, 4/29/2014, 5/5/2014, and 6/12/2014.

    Distribution

    Worldwide Distribution: US (nationwide) in states of Ohio, Oregon, New Mexico, North Carolina, Texas and to the following countries: Australia, Canada, Hong Kong, Iceland, Japan, Lebanon, Singapore, Thailand, and United Kingdom.

    Quantity

    total 3633 units (3342 units in US and 291 units Outside US)