Events

Retiro De Equipo (Recall) de Covidien Curity Eye Pad, Curity Eye Pad Oval, Curity Sodium Chloride Dressing Covidien Curity Eye Pad

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Covidien 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-2017-RN-00354-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-03-17
  • 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-2017-RN-00354-1
  • 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
    There is a potential for the sterile packaging of the covidien curity eye pad, curity eye pad oval and curity sodium chloride dressing to be compromised. hence, the use of products with this issue may result in an increased risk of infection. to date, there have been no reports of infection associated with this issue.
  • Acción
    Medtronic is advising customers to quarantine and discontinue the use of affected stock. Customers are also requested to label the stock with the provided ZRE # (number) prior to their return to Medtronic whereby customers will receive credit to the value of the returned stock.

Device

Covidien Curity Eye Pad, Curity Eye Pad Oval, Curity Sodium Chloride Dressing Covidien Curity Eye...
  • Modelo / Serial
    Covidien Curity Eye Pad, Curity Eye Pad Oval, Curity Sodium Chloride Dressing Covidien Curity Eye Pad Item Code: 03201Lot Numbers beginning with 12, 13, 14, 15 and16Covidien Curity Eye Pad OvalItem Code: 2841Lot Numbers beginning with 12, 13, 14, 15 and16Covidien Curity Sodium Chloride Dressing Item Code: 3339Lot Number beginning with 14, 15, 16 (Excluding lots: 16J098062, 16J098162, 16J098262)ARTG Numbers: 186368, 186373
  • Manufacturer
    Covidien Pty Ltd

Manufacturer

Covidien Pty Ltd
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DHTGA