Events

Retiro De Equipo (Recall) de CUSTOM STERILE RIGHT COLECTOMY PACK

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
    60295
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2011-01-31
  • 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
    The triad sterile lube jelly component recall has been initiated due to concerns expressed by fda regarding the validation of the gamma radiation sterilization cycles for these products. cardinal health canada couriered a recall notification to affected customers on jan. 28 2011.

Device

CUSTOM STERILE RIGHT COLECTOMY PACK
  • Modelo / Serial
    Model Catalog: SBA30CD'XXX' (Lot serial: MORE THAN 10 WORK ORDER #S.); Model Catalog: SBA30UPXXX (Lot serial: MORE THAN 10 WORK ORDER #S.); Model Catalog: SUT30CAXXX (Lot serial: MORE THAN 10 WORK ORDER #S.); Model Catalog: SBA30TVXXX (Lot serial: MORE THAN 10 WORK ORDER #S.); Model Catalog: SCV30VAXXX (Lot serial: MORE THAN 10 WORK ORDER #S.); Model Catalog: SBA30BLXXX (Lot serial: MORE THAN 10 WORK ORDER #S.); Model Catalog: SBA30RBXXX (Lot serial: MORE THAN 10 WORK ORDER #S.); Model Catalog: SMA30DL'XXX' (Lot serial: MORE THAN 10 WORK ORDER #S.); Model Catalog: SMA30VHXXX (Lot serial: MORE THAN 10 WORK ORDER #S.); Model Catalog: SMA30VLXXX (Lot serial: MORE THAN 10 WORK ORDER #S.); Model Catalog: SMA30PNXXX (Lot serial: MORE THAN 10 WORK ORDER #S.); Model Catalog: SOT30RPXXX (Lot serial: MORE THAN 10 WORK ORDER #S.); Model Catalog: SOT30PRXXX (Lot serial: MORE THAN 10 WORK ORDER #S.); Model Catalog: SBA30TPXXX (Lot serial: MORE THAN 10 WORK ORDER #S.); Model Catalog: SBA30RPXXX (Lot serial: MORE THAN 10 W
  • Descripción del producto
    CUSTOM STERILE RIGHT COLECTOMY PACK
  • Manufacturer
    CARDINAL HEALTH CANADA INC.

Manufacturer

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