Events

Retiro De Equipo (Recall) de Device Recall Part : SAM XTM, Model: Tactical Black or Military

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por The Seaberg Company Inc.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    80140
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2226-2018
  • Fecha de inicio del evento
    2018-05-02
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164666
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Tourniquet, nonpneumatic - Product Code GAX
  • Causa
    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.
  • Acción
    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.

Device

Device Recall Part : SAM XTM, Model: Tactical Black or Military
  • Modelo / Serial
    Lot #: XT1711, XT1712, XT1713, XT1715, XT1719, XT1720, XT1721, XT1722, XT1723, XT1724, XT1725, XT1726, XT1727, XT1728, XT1729, XT1730, XT1731, XT1732, XT1734, XT1737, XT1738, XT1740, XT1742, XT1743, XT1744, XT1745, XT1746, XT1747, XT1748, XT1749, XT1750, XT1751, XT1752, XT1801, XT1803, XT1804, XT1805, XT1806, XT1807, XT1808, XT1809, XT1810, XT1811
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    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
  • Descripción del producto
    Part #: SAM XT-M, Model: Tactical Black or Military
  • Manufacturer
    The Seaberg Company Inc

Manufacturer

The Seaberg Company Inc
  • Dirección del fabricante
    The Seaberg Company Inc, 27350 SW 95th Ave Ste 3038, Wilsonville OR 97070-7709
  • Empresa matriz del fabricante (2017)
    The Seaberg Company Inc
  • Source
    USFDA