Events

Retiro De Equipo (Recall) de 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
    Recall
  • ID del evento
    69194
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-2714-2014
  • Fecha de inicio del evento
    2014-09-08
  • Fecha de publicación del evento
    2014-09-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-08-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129831
  • 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
    Circuit, breathing (w connector, adaptor, y piece) - Product Code CAI
  • Causa
    The pediatric breathing circuits can crack prior to and during use.
  • Acción
    Teleflex Medical sent an Urgent Medical Device Recall dated September 8, 2014, to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to immediately discontinue use, quarantine any products with the product codes and lot numbers provided in the notification, return any affected product, complete and return the enclosed Recall Acknowledgement Form and fax it to the attention of Customer Service. For questions contact your local sales representative or Customer Service at 1-866-246-6990.

Device

Hudson RCI
  • Modelo / Serial
    Product Code: 313905, Lot #02F1300085; Product Code: 353900, Lot #02D1300584; Product Code: 353901, Lot #0241300618; Product Code: 353911, Lot #02G1300296, 02G1300861, 02F1300729; Product Code: 313901, Lot #02G1300088; Product Code: 353811, Lot #02E1300090; 02E1301383 & 02E1301867; Product Code: 353911, Lot #02F1300102 & 02F1300177; Product Code: 353900, Lot #02F1302029; Product Code: 353801, Lot #02E1300623, 02FF1300098, 02H1300172, 02H1300454, 02H1301128, 02F300180, 02E1301891, 02J1300876, 02H1301838, 02J1302412 & 02B1400324; Product Code: 353901, Lot #02E1301378; Product Code: 353900, Lot #02E1301892, 02F1300100 and Product Code: 353901, Lot #02F1302047, 02F1300101 & 2G1300879.
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide in the states of AZ, CA, FL, IL, KY, OH, NJ, NY, TX, LA, OR, SD, WA, including Puerto Rico, and the countries of Belgium, Canada, Chile, China, Colombia, Korea, Mexico, Peru, Venezuela and Zaire.
  • Descripción del producto
    Hudson RCI¿ Pediatric Anesthesia Breathing Circuits, Single Patient Use, Rx Only, || Product Usage: To administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Ypiece.
  • 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