Events

Retiro De Equipo (Recall) de CONTACT DETACH INFUSION SETS

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por LIFESCAN CANADA A DIVISION OF JOHNSON & JOHNSON 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
    90242
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-11-24
  • 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
    Manufacturer has identified an increase in reports of the tubing becoming detached at the connect/disconnect location. if tubing detachment occurs insulin delivery is interrupted and the pump will not alarm to notify patients. the interruption of insulin delivery can cause hyperglycemia which if left untreated can result in diabetic ketoacidosis (dka). dka is a serious condition that can cause a severe impact to health including death. symptoms of dka may include nausea vomiting shortness of breath and excess thirst/urination. manufacturer is advising patients to seek medical attention immediately if they are experiencing any of these symptoms.

Device

CONTACT DETACH INFUSION SETS
  • Modelo / Serial
    Model Catalog: 10090503 (Lot serial: > 10 numbers contact mfg); Model Catalog: 10000601 (Lot serial: > 10 numbers contact mfg); Model Catalog: 10000602 (Lot serial: > 10 numbers contact mfg); Model Catalog: 10000603 (Lot serial: > 10 numbers contact mfg); Model Catalog: 10000600 (Lot serial: > 10 numbers contact mfg); Model Catalog: 10090502 (Lot serial: > 10 numbers contact mfg); Model Catalog: 10090501 (Lot serial: > 10 numbers contact mfg); Model Catalog: 10090500 (Lot serial: > 10 numbers contact mfg); Model Catalog: 10024005 (Lot serial: 5052070); Model Catalog: 10024004 (Lot serial: 5052070); Model Catalog: 10024003 (Lot serial: 5052070); Model Catalog: 10024001 (Lot serial: 5052070); Model Catalog: 89-060-2522 (Lot serial: 5052070); Model Catalog: 10024005 (Lot serial: > 10 numbers contact mfg); Model Catalog: 10024004 (Lot serial: > 10 numbers contact mfg); Model Catalog: 10024003 (Lot serial: > 10 numbers contact mfg); Model Catalog: 10024001 (Lot serial: > 10 numbers contact mfg); Model Catalog: 89
  • Descripción del producto
    Contact Detach Infusion Sets
  • Manufacturer
    LIFESCAN CANADA A DIVISION OF JOHNSON & JOHNSON INC.

Manufacturer

LIFESCAN CANADA A DIVISION OF JOHNSON & JOHNSON INC.
  • Dirección del fabricante
    BURNABY
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    HC