Events

Retiro De Equipo (Recall) de LAPARATOMY/LAPAROSCOPY PACKS

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por CARDINAL HEALTH CANADA 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
    27678
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-07-11
  • 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
    Cardinal health has recently been informed by conmed corporation that they have initiated a recall of various core? suction irrigation handpieces which are found in presource kits. this action has been initiated due to identification of product with creases in the packaging seal which sometimes result in an open channel.

Device

LAPARATOMY/LAPAROSCOPY PACKS
  • Modelo / Serial
    Model Catalog: SBA30ELVOG (Lot serial: 178043); Model Catalog: SBA30NPCLB (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: SBA30NPCLC (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: SBA30NPCLD (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: SBA30ELVOG (Lot serial: 174591); Model Catalog: SBA30ELVOG (Lot serial: 172717); Model Catalog: SBA30ELVOG (Lot serial: 179938); Model Catalog: SBA30LCPOB (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: SBA30LCPOA (Lot serial: > 10 NUMBERS CONTACT MFG)
  • Descripción del producto
    ENSEMBLE ENDO CHOLECYSTECTOMIE;STERILE ENSEMBLE NEPHRECTOMIE;STR LAPAROSCOPIC PORTAGE PACK
  • Manufacturer
    CARDINAL HEALTH CANADA INC.

Manufacturer

CARDINAL HEALTH CANADA INC.
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    Cardinal Health
  • Source
    HC