Events

Retiro De Equipo (Recall) de Device Recall Device, fixation, tracheal tube

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 Dale Medical Products, Inc..

¿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
    76965
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1928-2017
  • Fecha de inicio del evento
    2017-03-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-05-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154789
  • 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
    Device, fixation, tracheal tube - Product Code CBH
  • Causa
    Et tube holders contain an adhesive faceplate that may lose its adhesive properties and will not adhere to the patient's face.
  • Acción
    Dale Medical notified accounts (OUS) on March 24, 2017 and US accounts on April 7, 2017 advising them to review inventory, if you have any of the noted Lot numbers in stock contact your customers that may have received the identified lot numbers of 270 ET Tube holders and remove suspected product.. Dale Medical will replace product. For questions customers were instructed to call 508-695-9316 ext. 143

Device

Device Recall Device, fixation, tracheal tube
  • Modelo / Serial
    Lot Numbers: 04 07 16 04, 08 16, 05 16 16
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -US ( Nationwide) and Internationally to Canada, Costa Rica, Norway, Paraguay, Ireland, Panama, Ecuador, Hong Kong, Malaysia, Italy, UAE, Guatemala, Iceland, Indonesia, and Saudi Arabia.
  • Descripción del producto
    Dale Medical Stabilock Endotracheal Adhesive Base || Product # 273 || The Dale Stabilock Endotracheal Tube Bolder 270 is a 2 piece device consisting of an adhesive base, Dale product number 273, that attaches to the patient's skin and a cushioned neckband with tube channel that attaches with hook & loop closures. The 270 is used to secure and stabilize endotracheal tubes, preventing unnecessary movement which can help prevent accidental .extubation
  • Manufacturer
    Dale Medical Products, Inc.

Manufacturer

Dale Medical Products, Inc.
  • Dirección del fabricante
    Dale Medical Products, Inc., 7 Cross St, Plainville MA 02762-1525
  • Empresa matriz del fabricante (2017)
    Dale Medical Products Inc.
  • Source
    USFDA