Events

Retiro De Equipo (Recall) de Device Recall Beacon Tip Royal Flush Plus HighFlow Catheter

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 Cook 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
    71692
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-2318-2015
  • Fecha de inicio del evento
    2015-07-02
  • Fecha de publicación del evento
    2015-08-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-09-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138758
  • 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
    Catheter, intravascular, diagnostic - Product Code DQO
  • Causa
    Reports of catheter tip splits and or separation. loss of device function, medical intervention to retrieve separated segment, or complications resulting from separated tip occluding blood flow to end organs may result.
  • Acción
    Cook Medical sent an Urgent Medical Device Recall letter dated July 2, 2015, to all affected customers. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification and instructions for returning the affected product. All customers were notified via courier. Customers with questions were instructed to contact Cook Medical Customer Relations at (800) 457-4500 or (812) 339-2235. Firm issued press release 8/3/2015.

Device

Device Recall Beacon Tip Royal Flush Plus HighFlow Catheter
  • Modelo / Serial
    All lots of the following Product numbers: HNR4.0-35-100-P-10S-0,  HNR4.0-35-100-P-10S-CFP,  HNR4.0-35-100-P-10S-PIG,  HNR4.0-35-100-P-6S-VCF,  HNR4.0-35-100-P-NS-0, HNR4.0-35-100-P-NS-DAV,  HNR4.0-35-100-P-NS-SIM1,  HNR4.0-35-100-P-NS-SIM2,  HNR4.0-35-100-ST-10S-0, HNR4.0-35-100-ST-10S-PIG,  HNR4.0-35-100-ST-6S-PED,  HNR4.0-35-110-P-10S-PIG,  HNR4.0-35-120-P-6S-PED, HNR4.0-35-120-ST-6S-PED,  HNR4.0-35-125-P-10S-0,  HNR4.0-35-125-P-10S-PIG,  HNR4.0-35-50-P-NS-0,  HNR4.0-35-65-P-8S-VCF, HNR4.0-35-70-P-10S-0,  HNR4.0-35-70-P-10S-CFP,  HNR4.0-35-70-P-10S-PIG,  HNR4.0-35-70-P-4S-PED,  HNR4.0-35-70-P-6S-PED, HNR4.0-35-70-P-NS-0,  HNR4.0-35-70-ST-10S-0,  HNR4.0-35-70-ST-10S-PIG,  HNR4.0-35-70-ST-6S-PED,  HNR4.0-35-90-P-10S-0, HNR4.0-35-90-P-10S-CFP,  HNR4.0-35-90-P-10S-PIG,  HNR4.0-35-90-P-6S-PED,  HNR4.0-35-90-P-8S-VCF,  HNR4.0-35-90-P-NS-0, HNR4.0-35-90-ST-10S-0,  HNR4.0-35-90-ST-10S-PIG
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide including Puerto Rico and US Virgin Islands), Algeria, Antigua, Armenia, Austria, Australia, Bahamas, Belgium, Bangladesh, Bulgaria, Bahrain, Brazil, Brunei Darussalam, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, El Salvador, Finland, France, French Polynesia, Georgia, Germany, Ghana, Great Britain, Greece Guadeloupe, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kuwait, Kazakhstan, Republic of Korea, Kuwait, Lebanon, Lithuania, Luxemburg, Latvia, Libya, Macau, Malaysia, Malta, Martinique, Mexico, Mongolia, Morocco, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Sri Lanka, Sweden, Switzerland, Spain, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.
  • Descripción del producto
    Beacon Tip Royal Flush Plus High-Flow Catheter. Angiographic catheter. || For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into the vascular system over an appropriately sized wire guide.
  • Manufacturer
    Cook Inc.

Manufacturer

Cook Inc.
  • Dirección del fabricante
    Cook Inc., 750 N Daniels Way, Bloomington IN 47404-9120
  • Empresa matriz del fabricante (2017)
    Cook Group Incorporated
  • Source
    USFDA