Events

Retiro De Equipo (Recall) de Various Kits containing Anticoagulant Citrate Dextrose Solution, Solution A (ACDA) 30mL Vials (Supplied in apheresis and surgical procedure kits) Affected kits:BIOCUE STD KIT ACD-A W/BD, SINGLE KIT W/BLOOD DRAW, GPS BONE BIOLOGICS KIT 20mL + S.TUBE, 2MARROWSTIM CALCIBON KIT 20mL, MARROWBIOCUE CALCIBON KIT 20mL

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Zimmer Pty Ltd.

¿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
    RC-2016-RN-01011-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-08-01
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01011-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Zimmer biomet has initiated this action following an investigation which identified a defect with the acda 30 ml vial known as a split finish that could compromise product sterility. split finishes occur during the glass bottle manufacturing process. the data shows that the risk of a sterility breach is rare <1% and the risk of injury to patients is remote <0.1%. use may result in an infection. there have been no reported complaints to date.
  • Acción
    Zimmer Biomet is advising users inspect and quarantine affected stock for return. This action has been closed-out on 02/03/2017.

Device

Various Kits containing Anticoagulant Citrate Dextrose Solution, Solution A (ACDA) 30mL Vials (Su...
  • Modelo / Serial
    Various Kits containing Anticoagulant Citrate Dextrose Solution, Solution A (ACDA) 30mL Vials (Supplied in apheresis and surgical procedure kits)Affected kits:BIOCUE STD KIT ACD-A W/BDProduct Number: 800-0613A GPS3 SINGLE KIT W/BLOOD DRAWProduct Number: 800-0675A GPS BONE BIOLOGICS KIT 20mL + S.TUBEProduct Number: TCP20GPSS.2MARROWSTIM CALCIBON KIT 20mLProduct Number: TCP20MARROWBIOCUE CALCIBON KIT 20mLProduct Number: TCP20BIOCUE ARTG #: 183209, 100053, 127024
  • Manufacturer
    Zimmer Pty Ltd

Manufacturer

Zimmer Pty Ltd
  • Empresa matriz del fabricante (2017)
    Zimmer Biomet Holdings
  • 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
    DHTGA