Device Recall Hudson RCI Infant Nasal CPAP Cannula, Size 1

  • Modelo / Serial
    catalog no. 1691, lot numbers 33069/22206, 33069/22306;  catalog no. 41691, lot number 32069/21406, 33069/21906; catalog no. 1685, lot numbers 32069/21506, 32069/21606
  • Clasificación del producto
  • 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 1; 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 configurations: || a) catalog No. 1691and 41691 (International): 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; || b) catalog No. 1685: Infant CPAP System intended for use with a water seal or spring loaded valve, and includes one cannula with one inspiratory and one expiratory elbow conenctor, two 4 ft. lengths of 10mm I.D. corrugated tubing, one 4 ft. pressure monitoring line, one 22mm to 10mm humidifier adapter, one knit cap and two 6 inch sections of Velcro securing tape;
  • Manufacturer
  • 1 Event

Fabricante

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