Retiro De Equipo (Recall) de GPS III MINI PLATELET CONCENTRATE SEPARATION KIT W/ACD-A

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por ZIMMER BIOMET 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
    25354
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-07-15
  • 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
    Biomet biologics has initiated a recall of various kits which contain defective acd-a 30ml vials. these vials may have a split finish which occurs during the glass bottle manufacturing process. this defect could compromise product sterility. the risk of sterility breach is estimated as rare less than 1% and the risk of injury to patients is remote less than 0.1%.

Device

  • Modelo / Serial
    Model Catalog: 800-0670A (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 800-0505A (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 800-0516 (Lot serial: 400403); Model Catalog: 800-0675A (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 800-1003A (Lot serial: >10 NUMBERS CONTACT MFR)
  • Descripción del producto
    GPS III MINI PLATELET CONCENTRATE KIT;PLASMAX W/ GPS III MINI CONCENTRATE KIT;GPS III PLATELET CONCENTRATE KIT
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    HC