Events

Retiro De Equipo (Recall) de Device Recall Cook Vacuum Pump

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
    79713
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1461-2018
  • Fecha de inicio del evento
    2018-03-22
  • 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=163165
  • 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
    Accessory, assisted reproduction - Product Code MQG
  • Causa
    Pump was found to be constructed from crimp connectors that do not meet the fixation wiring requirements and can cause failure of the device to operate or electric shock or burn to the user.
  • Acción
    An Urgent: Medical Device Correction letter, dated March 20, 2018, was sent to consignees. The letter identified the affected device and provided a description of the problem. The firm stated that it would be replacing the mains wiring for each unit. An authorized service agent will contact customers to arrange for the affected devices to be corrected. Customers are to follow the instructions regarding the residual current device (RCD) provided in the letter, while they are waiting for their devices to be corrected. Additionally, customers should complete the Acknowledgement and Receipt Form within 5 business days of receiving the letter. Questions or concerns should be directed to Cook Medical Capital Equipment Service at 855-207-7214.

Device

Device Recall Cook Vacuum Pump
  • Modelo / Serial
    All lots
  • Clasificación del producto
    Obstetrical and Gynecological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA, Argentina, Bolivia, Brazil, Canada, Colombia, Guatemala, Mexico, Panama, Peru, Uruguay, and Venezuela.
  • Descripción del producto
    Cook Vacuum Pump ( Cook Aspiration Unit) K-MAR-5200-US, GPN G49275. || Intended for the aspiration of body fluids and cells, in particular oocyte aspiration.
  • 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