Events

Retiro De Equipo (Recall) de AMSCO EVOLUTION PREVACUUM STEAM STERILIZER

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

¿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
    76175
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2013-10-18
  • 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 amsco evolution steam sterilizers utilize a loading system to assist the operator in transporting loading and unloading items to be sterilized. off-label use of transfer carriages by customers is resulting in minor injuries such as strained backs. despite repeated in-services these injuries are occurring when operators are pushing/maneuvering carriages that have been overloaded or not loaded evenly.

Device

AMSCO EVOLUTION PREVACUUM STEAM STERILIZER
  • Modelo / Serial
    Model Catalog: UE44-XXX-XXX-XXX (Lot serial: 030061103 thru 0535531220); Model Catalog: UE43-XXX-XXX-XXX (Lot serial: 030061103 thru 0535531220); Model Catalog: UE26-XXX-XXX-XXX (Lot serial: 030061103 thru 0535531220); Model Catalog: UE25-XXX-XXX-XXX (Lot serial: 030061103 thru 0535531220); Model Catalog: UE24-XXX-XXX-XXX (Lot serial: 030061103 thru 0535531220); Model Catalog: UE06-XXX-XXX-XXX (Lot serial: 030061103 thru 0535531220); Model Catalog: UE05-XXX-XXX-XXX (Lot serial: 030061103 thru 0535531220); Model Catalog: UE04-XXX-XXX-XXX (Lot serial: 030061103 thru 0535531220); Model Catalog: UE42-XXX-XXX-XXX (Lot serial: 030061103 thru 0535531220); Model Catalog: UE41-XXX-XXX-XXX (Lot serial: 030061103 thru 0535531220); Model Catalog: UE23-XXX-XXX-XXX (Lot serial: 030061103 thru 0535531220); Model Catalog: UE22-XXX-XXX-XXX (Lot serial: 030061103 thru 0535531220); Model Catalog: UE21-XXX-XXX-XXX (Lot serial: 030061103 thru 0535531220); Model Catalog: UE03-XXX-XXX-XXX (Lot serial: 030061103 thru 0535531220); M
  • Descripción del producto
    AMSCO EVOLUTION MEDIUM STEAM STERILIZER ACCESSORY-EVOLUTION TRANSFER CARRIAGE
  • Manufacturer
    STERIS CANADA INCORPORATED

Manufacturer

STERIS CANADA INCORPORATED
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    Steris Plc
  • Source
    HC