Retiro De Equipo (Recall) de Device Recall HUDSON RCI

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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Tube, tracheal/bronchial, differential ventilation (w/wo connector) - Product Code CBI
  • Causa
    The double swivel connector may crack or separate on the endobronchial tube.
  • Acción
    Teleflex Medical sent an Urgent Medical Device Recall Notification letter dated June 1, 2015 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were directed to contact any customers who had received the product included within the scope of this recall. Customers were directed to immediately discontinue use and quarantine any products with the referenced catalog numbers and lot numbers listed in the notification. Additionally, customers were asked to return any affected product together with a completed Recall Acknowledgement Form, for consolidation and return to Teleflex Medical. For questions contact your local sales representative or Customer Service at 1-866-246-6990.


  • Modelo / Serial
    Product Code: 5-16128, Lot numbers: 73L1400012, 73K1400582, 73L1400233 and 73A1500039; Product Code: 5-16135, Lot numbers: 73B1500259, 73B1500293, 73C1500401, 73C1500426, 01K1300470, 01B1400479, 73D1400498, 73F1400096, 73H1400443, 73J1400117, 73K1400583, 73L1400094, 73A1500205, 73A1500206 and 73B1500258; Product Code: 5-16137, Lot numbers: 73B1500354, 73B1500355, 73C1500402 and 73C1500427; Product Code: 5-16139, Lot numbers: 73G1400177, 73H1400444, 73L1400095, 73A1500041 and 73A1500203; Product Code: 5-16141, Lot numbers: 01L1300156, 01A1400452, 73G1400178, 73G1400510, 73H1400009, 73K1400553 and 73B1500257.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution - US (nationwide) and the countries of: The Bahamas, Belgium, Argentina, Canada, China, India, Japan, South Korea, Mexico, New Zealand and Vietnam.
  • Descripción del producto
    HUDSON RCI, Sheridan Sher-I-BRONCH, Endobronchial Tube (Right sided), Sizes: 28 Fr., 35 Fr., 37 Fr., 39 Fr. and 41 Fr., Rx Only, Sterile. || Intended for use in thoracic surgery, bronchospirometry, for the administration of bronchial anesthesia and other uses commonly requiring bronchial intubation.
  • Manufacturer


  • Dirección del fabricante
    Teleflex Medical, 2917 Weck Dr, Research Triangle Park NC 27709-0186
  • Empresa matriz del fabricante (2017)
  • Source