Events

Retiro De Equipo (Recall) de Device Recall AquaPak Sterile Water for Inhalation, USP, 760 mL

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
    34120
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0503-06
  • Fecha de inicio del evento
    2005-12-01
  • Fecha de publicación del evento
    2006-02-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2006-05-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43154
  • 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
    Teleflex medical determined that the distribution center shipped unreleased product which did not pass validated sterility test requirements.
  • Acción
    Teleflex Medical sent recall letters dated 12/1/05 to their direct accounts on the same date via UPS overnight. The accounts were informed that the lot did not pass validated sterility test requirements, and were instructed to cease distribution and use of the lot and quarantine it for return to Teleflex Medical, Durham, NC. The wholesalers were requested to notify their customers of the recall and have them return their inventory of the lot to the direct account for consolidation and return to Teleflex. Questions were directed to Dan Daily at 1-800-334-9751, ext. 4948.

Device

Device Recall AquaPak Sterile Water for Inhalation, USP, 760 mL
  • Modelo / Serial
    catalog number 037-00, lot 150150, exp. 2009-10
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Colorado, Nebraska, Oregon, Minnesota, California, Pennsylvania, Michigan, Louisiana, Oklahoma and Texas.
  • Descripción del producto
    AquaPak Sterile Water for Inhalation, USP, 760 mL blow-molded plastic bottle for use with a respiratory gas humidifier; 10 bottles per case; manufactured by Hudson Respiratory Care, Inc., Temecula, CA 92589-9020 USA; catalog #037-00
  • Manufacturer
    Teleflex Medical

Manufacturer

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