Events

Retiro De Equipo (Recall) de STERRAD 100S Cassettes

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Johnson & Johnson Medical 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-2014-RN-00281-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2014-03-04
  • 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-2014-RN-00281-1
  • 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
    The manufacturer, asp has identified that the misaligned barcodes may cause the cassette to be slightly out of position. the barcode on the sterrad 100s cassette is used to register the position of the cassette in the sterilizer. an out of position cassette may cause the first cycle on that cassette to cancel, or in extreme cases may cause the injection needles used to remove hydrogen peroxide from the sterrad 100s cassette to be damaged. the position of the barcode on the affected lots is variable and the probability of resulting damage to the injection needles is low.
  • Acción
    Johnson & Johnson Medical is advising users to continue to use current stock until a replacement product has been provided. Affected stock can be returned to Johnson & Johnson Medical once unaffected stock has been received. This action has been closed-out on 12/02/2016.

Device

STERRAD 100S Cassettes
  • Modelo / Serial
    STERRAD 100S CassettesProduct Code: 10113Lot Numbers; 13I038, 13I046, 13I071, 13I072, 13I077, 13I078, 13I083, 13I084, 13I090, 13I121, 13K003, 13K074, 13K105, 13L021, 14A030 & 14A031ARTG Number: 123602
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd