Retiro De Equipo (Recall) de SENSICARE LT WITH ALOE SURGICAL GLOVES

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por MEDLINE CANADA CORPORATION.

¿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
    34474
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2016-08-16
  • País del evento
  • 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
    The expiry date indicated on the outer case and dispenser box is two years later than the actual expiry on the inner pouch. also the inner pouch contains a different product code than the outer case and dispenser box.

Device

  • Modelo / Serial
    Model Catalog: MSG1180 (Lot serial: >10 lot numbers contact MFG); Model Catalog: MSG1160 (Lot serial: >10 lot numbers contact MFG); Model Catalog: MSG1165 (Lot serial: >10 lot numbers contact MFG); Model Catalog: MSG1190 (Lot serial: >10 lot numbers contact MFG); Model Catalog: MSG1185 (Lot serial: >10 lot numbers contact MFG); Model Catalog: MSG1155 (Lot serial: >10 lot numbers contact MFG); Model Catalog: MSG1175 (Lot serial: >10 lot numbers contact MFG); Model Catalog: MSG1170 (Lot serial: >10 lot numbers contact MFG); Model Catalog: MSG1055 (Lot serial: > 10 Lot numbers contact MFG); Model Catalog: MSG1080 (Lot serial: > 10 Lot numbers contact MFG); Model Catalog: MSG1075 (Lot serial: > 10 Lot numbers contact MFG); Model Catalog: MSG1065 (Lot serial: > 10 Lot numbers contact MFG); Model Catalog: MSG1085 (Lot serial: > 10 Lot numbers contact MFG); Model Catalog: MSG1060 (Lot serial: > 10 Lot numbers contact MFG); Model Catalog: MSG1090 (Lot serial: > 10 Lot numbers contact MFG); Model Catalog: MSG1070 (Lo
  • Descripción del producto
    Sensicare LT with aloe surgical gloves;Sensicare with aloe surgical gloves
  • Manufacturer

Manufacturer