Retiro De Equipo (Recall) de MED-RX EPIDURAL ANESTHESIA KIT

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por CANADIAN HOSPITAL SPECIALTIES LTD. DOING BUSINESS AS CHS.

¿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
    41759
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2017-01-30
  • 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
    Bd has received reports of safety cover disengagement and needlestick injury (nsi). this bd part is packaged in a range of chs med-rex products.

Device

  • Modelo / Serial
    Model Catalog: 80-8155 (Lot serial: all); Model Catalog: 80-8154 (Lot serial: all); Model Catalog: 80-8139 (Lot serial: all); Model Catalog: 80-8136 (Lot serial: all); Model Catalog: 80-8092 (Lot serial: all); Model Catalog: 80-8055 (Lot serial: all); Model Catalog: 80-8036 (Lot serial: all); Model Catalog: 80-8002 (Lot serial: all); Model Catalog: 80-7055 (Lot serial: all); Model Catalog: 80-7048 (Lot serial: all); Model Catalog: 80-7053 (Lot serial: all); Model Catalog: 80-7021 (Lot serial: all); Model Catalog: 80-7018 (Lot serial: all); Model Catalog: 80-7025 (Lot serial: all); Model Catalog: DYNJRA0530 (Lot serial: all); Model Catalog: 80-9108 (Lot serial: all); Model Catalog: 80-9092 (Lot serial: all); Model Catalog: 80-9070 (Lot serial: all); Model Catalog: 80-9013 (Lot serial: all); Model Catalog: 80-9046 (Lot serial: all); Model Catalog: 80-9023 (Lot serial: all); Model Catalog: 80-9021 (Lot serial: all); Model Catalog: 80-9019 (Lot serial: all); Model Catalog: 80-9063 (Lot serial: all); Model Catalo
  • Descripción del producto
    MED-RX EPIDURAL ANESTHESIA KIT;MED-RX UNIVERSAL ANESTHESIA KITS;MED-RX PARA/THORACENTESIS KIT;MED-RX SPINAL ANESTHESIA KITS;SUTURE/LACERATION TRAY;BIOPSY TRAY;MED-RX DRESSING TRAY
  • Manufacturer

Manufacturer