Events

Retiro De Equipo (Recall) de Device Recall Argon Medical Devices Catheter Introducer Kit, PCI 5 Kit 7F

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 Argon Medical Devices, 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
    58289
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2083-2011
  • Fecha de inicio del evento
    2011-03-14
  • Fecha de publicación del evento
    2011-04-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-04-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98903
  • 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
    kit, plastic surgery and accessories - Product Code FTN
  • Causa
    Packaging for sterile tray has the potential to have a hole which could compromise sterility for the products inside.
  • Acción
    Argon Medical Devices sent an Urgent Medical Device Recall letter dated March 14, 2011, by certified mail to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to identify, quarantine and return any product remaining at their facility utilizing the instruction on the 2011 Tray Recall Response Form. Customers were instructed to complete the response form included with the letter and return by fax or email as indicated as soon as possible. Customers were instructed to pass the notice on to all those who need to be aware within their organization or to any organization where the potentially affected devices have been transferred. For questions regarding this recall call (903) 677-9375.

Device

Device Recall Argon Medical Devices Catheter Introducer Kit, PCI 5 Kit 7F
  • Modelo / Serial
    Lot number 99767488
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including AL, AZ, CA, CO, DE, GA, HI, IL, IN, LA, MD, MN, ND, NE, NH, NJ, NY, OK, PA, SC, TX, VA, WA, and WI and the countries of Nationwide, Japan, Australia, Canada, Singapore, and the Netherlands
  • Descripción del producto
    Argon Medical Devices Catheter Introducer Kit, PCI 5 Kit 7F, Part Number 496183, Lot Number 99767488 || Multi-purpose Kit blister tray coupled with Tyvek lid stock heat-sealed to form a sterile barrier. For percutaneous introduction of catheters.
  • Manufacturer
    Argon Medical Devices, Inc

Manufacturer

Argon Medical Devices, Inc
  • Dirección del fabricante
    Argon Medical Devices, Inc, 1445 Flat Creek Rd, Athens TX 75751
  • Empresa matriz del fabricante (2017)
    RoundTable Healthcare Partners Lp
  • Source
    USFDA