Events

Retiro De Equipo (Recall) de SAM Junctional Tourniquet (SJT) Auxiliary

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 Sam Medical Products.

¿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
    69395
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0133-2015
  • Fecha de inicio del evento
    2014-08-14
  • Fecha de publicación del evento
    2014-12-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-07-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130412
  • 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
    Clamp, vascular - Product Code DXC
  • Causa
    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.
  • Acción
    SAM Medical Products issued the press release on August 29, 2014 and the link is http://www.ireachcontent.com/news-releases/sam-medical-products-implements-voluntary-recall-of-its-accessory-axilla-strap-for-the-sam-junctional-tourniquet-273239381.html. SAM Medical Products sent the "URGENT: MEDICAL DEVICE RECALL" letter, dated September 10, 2014, to their consignees. The 5 additional lot numbers (7/1/14, 7/2/14, 8/4/14, 8/7/14, and 8/11/14) that were erroneously placed on the recall notification letter and they are NOT part of the recall. SAM Medical Distributors will need to notify their customers via this letter and the included FAX Back document of the actions being taken as well as ship the replacement straps to individual customers. Distributors will document and report to SAM Medical that all customers have been notified and replacement straps delivered to these customers. Distributors will notify SAM Medical that the replaced straps have been destroyed. This information will be documented on the included FAX Back document and then returned to SAM Medical (via FAX, e-mail, or mail, per instructions on the FAX Back document). Customers will receive one complete Auxiliary Accessory Strap at no charge with a reinforced metal clip as a replacement. Once received, the existing strap should be removed from the SJT and replaced with the new strap. Customers/End Users need to complete and return the FAX Back document to the distributor from whom the FAX Back was sent. Customer can contact SAM Medical Customer Service at: -Email customerservice@sammedical.com -Phone (503) 639-5474, Monday through Friday, 7:30-4:30, Pacific Time -Toll free l-800-818-4726 -Website: vww.sammedical.com

Device

SAM Junctional Tourniquet (SJT) Auxiliary
  • Modelo / Serial
    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.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    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.
  • Descripción del producto
    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.
  • Manufacturer
    Sam Medical Products

Manufacturer

Sam Medical Products
  • Dirección del fabricante
    Sam Medical Products, 27350 SW 95th Ave Ste 3038, Wilsonville OR 97070-7709
  • Empresa matriz del fabricante (2017)
    Sam Medical Products
  • Source
    USFDA