Events

Retiro De Equipo (Recall) de NON-DEHP MICROBORE ADMINISTRATION SET

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por LYNDEN INTERNATIONAL LOGISTICS CO..

¿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
    16735
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2011-05-30
  • 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
    A defect with the resin used in tubing received from a supplier has been discovered. this has resulted in a rough texture on the inner and outer diameter of the tubing segment inserted into the pump. this could lead to the pump sensor registering an air bubble causing an unresolvable false air-in-line alarm even if no air bubble is present.

Device

NON-DEHP MICROBORE ADMINISTRATION SET
  • Modelo / Serial
    Model Catalog: 340-4168 (Lot serial: D100712); Model Catalog: 340-4126 (Lot serial: D024513); Model Catalog: 340-4126 (Lot serial: CF1020901); Model Catalog: 340-4126 (Lot serial: D017913); Model Catalog: 340-4126 (Lot serial: D016002); Model Catalog: 340-4126 (Lot serial: CF10120003); Model Catalog: 340-4126 (Lot serial: D015326); Model Catalog: 340-4126 (Lot serial: D013714); Model Catalog: 340-4126 (Lot serial: D010416); Model Catalog: 340-4126 (Lot serial: D010321); Model Catalog: 340-4115 (Lot serial: D004616); Model Catalog: 340-4134 (Lot serial: D008511); Model Catalog: 340-4115 (Lot serial: D008511); Model Catalog: 340-4134 (Lot serial: D010911); Model Catalog: 340-4115 (Lot serial: D010911); Model Catalog: 340-4134 (Lot serial: D017418); Model Catalog: 340-4115 (Lot serial: D017418); Model Catalog: 340-4134 (Lot serial: D004616); Model Catalog: 340-4115 (Lot serial: D017317); Model Catalog: 340-4134 (Lot serial: D017317)
  • Descripción del producto
    NON-DEHP MICROBORE ADMINISTRATION SET
  • Manufacturer
    LYNDEN INTERNATIONAL LOGISTICS CO.

Manufacturer

LYNDEN INTERNATIONAL LOGISTICS CO.