Events

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
    33983
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2016-08-19
  • 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
    Omega laboratories ltd. has issued a recall for the sodium chloride injection usp lot# 4g683. this lot may be found in your med-rx anesthesia kit. the product's shelf life is 48 months and the ph for this lot may become out of specification prior to expiry date. thus med-rx anesthesia kits containing lot# 4g683 should not be used.

Device

MED-RX EPIDURAL ANESTHESIA KIT
  • Modelo / Serial
    Model Catalog: 80-8083 (Lot serial: >10 lot numbers contact mfg); Model Catalog: 80-8042 (Lot serial: >10 lot numbers contact mfg); Model Catalog: 80-8135 (Lot serial: >10 lot numbers contact mfg); Model Catalog: 80-8131 (Lot serial: >10 lot numbers contact mfg); Model Catalog: 80-8091 (Lot serial: >10 lot numbers contact mfg); Model Catalog: 80-8090 (Lot serial: >10 lot numbers contact mfg); Model Catalog: 80-8074 (Lot serial: >10 lot numbers contact mfg); Model Catalog: 80-8066 (Lot serial: >10 lot numbers contact mfg); Model Catalog: 80-8061 (Lot serial: >10 lot numbers contact mfg); Model Catalog: 80-8060N (Lot serial: >10 lot numbers contact mfg); Model Catalog: 80-8082 (Lot serial: >10 lot numbers contact mfg); Model Catalog: 80-8040 (Lot serial: >10 lot numbers contact mfg); Model Catalog: 80-8034 (Lot serial: >10 lot numbers contact mfg); Model Catalog: 80-8033 (Lot serial: >10 lot numbers contact mfg); Model Catalog: 80-8026 (Lot serial: >10 lot numbers contact mfg); Model Catalog: 80-8025 (Lot seri
  • Descripción del producto
    MED-EX Epidural Anesthesia Kits
  • Manufacturer
    CANADIAN HOSPITAL SPECIALTIES LTD. DOING BUSINESS AS CHS

Manufacturer

CANADIAN HOSPITAL SPECIALTIES LTD. DOING BUSINESS AS CHS