Events

Retiro De Equipo (Recall) de Device Recall HUDSON RCI, Humidifier Adaptor

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 Teleflex Medical.

¿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
    59035
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2790-2011
  • Fecha de inicio del evento
    2011-06-06
  • Fecha de publicación del evento
    2011-07-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-05-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100876
  • 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
    Humidifier, respiratory gas, (direct patient interface) - Product Code BTT
  • Causa
    The packaging may not have been properly sealed, and therefore the sterility of the product cannot be guaranteed.
  • Acción
    Teleflex Medical sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated June 6, 2011 to all affected customers. The letter described the product, problem, and the action to be taken. The letter instructs customers to discontinue use and quarantine the affected product. Customers must complete and return a Recall Acknowledgement Form via fax to 1-866-804-9881, Attn: Customer Service. A representative will contact customers with instructions on how to return the affected product. Customers with no affected product are also instructed to complete and return the form to verify receipt of the notification. Contact Customer Service at 1-866-246-6990 if you have questions regarding this recall. and a record of returns. A third letter was addressed to the Risk Manager with the above instructions.

Device

Device Recall HUDSON RCI, Humidifier Adaptor
  • Modelo / Serial
    Catalog Number: 003-40, Lot numbers: 738107, 741107, 762107, 764107 and 766107; Catalog number: 003-40F, Lot number: 733107; Catalog number: 003-40J, Lot number: 740107; Catalog number: 000-40, Lot numbers: YK24 and YL11; Catalog number: 006-40, Lot number: 137106; Catalog number: 006-40F, Lot numbers: 122106 and 123106; Catalog number: 006-40J, Lot numbers: 135106 and 136106; Catalog number: 400340, Lot numbers: 730107, 731107, 732107, 734107 and 735107.
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution--USA (nationwide) including the states of AL, AZ, CA, CO, FL, GA, IL, IN, KS, KY, MI, MN, MO, MS, NM, NE, NY, OH, OK, PA, TX, VA, WI and WM and the countries of Japan, Philippines, and Thailand.
  • Descripción del producto
    HUDSON RCI, Humidifier Adaptor, Rx only, Teleflex Medical, Research Triangle Park, NC 27709. || Use to add water vapor to a dry medical gas for administration to a patient.
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical
  • Dirección del fabricante
    Teleflex Medical, 4024 Stirrup Creek Dr, Durham NC 27703-9000
  • Empresa matriz del fabricante (2017)
    Teleflex Incorporated
  • Source
    USFDA