Events

Retiro De Equipo (Recall) de Device Recall Hudson RCI Infant Nasal CPAP Cannula, Size 3

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
    37665
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0860-2007
  • Fecha de inicio del evento
    2007-03-23
  • Fecha de publicación del evento
    2007-06-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-11-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51258
  • 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
    CPAP - Product Code BZD
  • Causa
    The luer-port in the expiratory elbow may be occluded, which interferes with a ventilator's ability to detect an accurate pressure reading.
  • Acción
    Teleflex Medical sent Urgent Medical Device Recall letters dated 3/23/07 via UPS 2nd Day Air to the direct accounts, informing them that the luer-port in the expiratory elbow may be occluded, which interferes with a ventilator's ability to detect an accurate pressure reading. The accounts were requested to cease use of the affected units, remove them from use/stock, quarantine and destroy them. If the accounts further distributed the product, they were requested to conduct a sub-recall of the affected units from their customers. The accounts were instructed to complete and return by fax the enclosed Acknowledgement & Stock Status Form, indicating the number of units destroyed and if they are requesting replacement product. Any questions were directed to Linda Todd at 1-800-334-9751, ext. 4951.

Device

Device Recall Hudson RCI Infant Nasal CPAP Cannula, Size 3
  • Modelo / Serial
    Catalog no. 1693, lot numbers 32069/21406, 32069/21506
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide, including USA, Puerto Rico, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Dominican Republic, El Salvador, Germany, Guatemala, Hong Kong, India, Israel, Kuwait, Malaysia, Mexico, New Zealand, Paraguay, Peru, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, and Venezuela
  • Descripción del producto
    Infant Nasal CPAP Cannula, Size 3; an Rx infant nasal prong continuous positive airway pressure (CPAP) cannula one inspiratory and one expiratory elbow connector; 10 units per case; Teleflex Medical, Research Triangle Park, NC 27709 U.S.A., Made in Mexico; The cannulas are sold as components in the following configuration: catalog No. 1693: Infant CPAP Set intended for use with mechanical ventilators, which includes one cannula with one inspiratory and one expiratory elbow connector, two 10mm to 7.5mm adapters, one knit cap and two 6 inch sections of Velcro securing tape;
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical
  • Dirección del fabricante
    Teleflex Medical, 2345 Waukegan Rd Ste 120, Bannockburn IL 60015-1580
  • Source
    USFDA