Events

Retiro De Equipo (Recall) de DALE STABILOCK 270 ENDOTRACHEAL TUBE HOLDER

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada 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
    151752
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2017-04-17
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    Dale medical products inc. has identified an issue within some endotracheal tube holders (product# 270) manufactured between march and june of 2016. as a reminder these endotracheal tube holders contain the endotracheal tube holder itself along with an adhesive "faceplate" (individual product # 273). we have found that some et tube holders contain an adhesive faceplate that may lose its adhesive quality over time and therefore not perform as it should. by "over time" we mean while in storage awaiting use not after being applied.

Device

DALE STABILOCK 270 ENDOTRACHEAL TUBE HOLDER
  • Modelo / Serial
    Model Catalog: H84102701 (Lot serial: 06 02 16)
  • Descripción del producto
    Endotracheal Tube Holders
  • Manufacturer
    DALE MEDICAL PRODUCTS INC.

Manufacturer

DALE MEDICAL PRODUCTS INC.