Events

Retiro De Equipo (Recall) de General Laparoscopy Procedure Pack and Gynaecological Laparoscopy Procedure Pack containing CORE Suction Irrigation Handpiece (sterile) General Laparoscopy Procedure Pack

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Medline International Two Australia 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-00882-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-07-01
  • 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-00882-1
  • 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
    This letter is to inform users that medline is recalling two procedure packs, the general laparoscopy and the gynecological laparoscopy, as they contain a conmed core suction irrigation handpiece. medline was informed by conmed that the core suction irrigation handpiece may contain creases in the packaging seal which sometimes results in an open channel. these channels may compromise sterility of the product. there have been no reports of injuries as a result of this issue.
  • Acción
    Medline is advising users to check the procedure packs in stock, remove and retain the ConMed CORE suction Irrigation Handpiece for return. Medline will replace the affected handpieces with unaffected stock. This action has been closed-out on 20/01/2017.

Device

General Laparoscopy Procedure Pack and Gynaecological Laparoscopy Procedure Pack containing CORE ...
  • Modelo / Serial
    General Laparoscopy Procedure Pack and Gynaecological Laparoscopy Procedure Pack containing CORE Suction Irrigation Handpiece (sterile) General Laparoscopy Procedure PackProduct Codes: CSBABRMQ18A and CSBABRMQ18BGynecological Laparoscopy Procedure Pack Product Codes: CSMABRMQ10A and CSMABRMQ10BARTG Number: 137395
  • Manufacturer
    Medline International Two Australia Pty Ltd

Manufacturer

Medline International Two Australia Pty Ltd