Events

Retiro De Equipo (Recall) de Device Recall MODEL P8400 HANDLE

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 Hemostatix Medical Technologies LLC.

¿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
    56366
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2596-2010
  • Fecha de inicio del evento
    2010-07-27
  • Fecha de publicación del evento
    2010-09-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-11-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93307
  • 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
    electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • Causa
    Lack of sterility assurance.
  • Acción
    On July 27, 2010, the firm, Hemostatix Medical Technologies, LLC, notified their international distributor in Japan of the recall by email. Hemostatix sent an "URGENT: MEDICAL DEVICE RECALL" letter dated July 29, 2010, to U.S. customers delivered via FedEx Priority Overnight. All non-responding customers were to be notified by telephone after 2 weeks. The other international customer, Italy, were to be notified by email on July 30, 2010. The letter describes the product, problem and action to be taken by customers. The customers were instructed to immediately check their inventory and remove any affected product found; ensure that satellite facilities/clinics receive the recall notice; complete and return the Recall Response Form via fax to Hemostatix's international fax number at 901-261-0017, and contact the Customer Care Department's recall hotline at 901-261-0012 for further instructions, if they do have affected stock. If you have any questions or concerns, please feel free to contact our Customer Care Department at: 1-800-722-5735 in the USA or 1-901-261-0012 outside the USA.

Device

Device Recall MODEL P8400 HANDLE
  • Modelo / Serial
    LOT HMT0647
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA including CA, GA, LA, MA, MD, MO, NC, OH, OR, PA, SC, TX, VA, and WI; and countries of Japan and Italy.
  • Descripción del producto
    MODEL P8400 HANDLE WITH INTEGRATED CABLE, FOR USE WITH MODEL P8400 CONTROLLER, REF 7013-8050, QTY (1), STERILE EO, HEMOSTATIX MEDICAL TECHNOLOGIES, LLC, BARTLETT, TN 38133 USA, CE 0473, EU REP : QFI LTD, STRATFORD, LONDON E15 2ST UK || The Hemostatix Thermal Scalpel is a surgical instrument designed to retain the precise, clean cutting characteristics of the traditional steel scalpel while minimizing blood loss by simultaneously sealing blood vessels as they are cut, with minimum damage to surrounding tissue and virtually no muscle stimulation, using heat thermally conducted to the tissue from an elevated-temperature blade.
  • Manufacturer
    Hemostatix Medical Technologies LLC

Manufacturer

Hemostatix Medical Technologies LLC
  • Dirección del fabricante
    Hemostatix Medical Technologies LLC, 8400 Wolf Lake Dr Ste 109, Bartlett TN 38133-4189
  • Empresa matriz del fabricante (2017)
    Hemostatix Medical Technologies Llc
  • Source
    USFDA