Retiro De Equipo (Recall) de Waratah Private General Packs and Waratah Private Knee/Shoulder Arthro Pack(Surgical procedure packs)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Molnlycke Health Care 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Following notification from component supplier, convatec ltd concerning the 3m suction tube contained in some procedure packs, mölnlycke is issuing this recall for product correction notice for packs containing this suction tubing. convatec conducted an internal assessment of product complaints that they had received and has identified that the suction tubes are not meeting their manufacturer's specifications. specifically, the connector part for application to the suction devices in the lots affected by the recall, has failed to meet its required reliability. the connector parts of the specified lots have a higher probability to crack once applied to suction devices outlets.
  • Acción
    Customers are advised to isolate all affected, unused packs at their facility and contact Mölnlycke representative for alternative single packed sterile suction tubing. At the point of use, it is recommended that the users remove the ConvaTec 3m Suction Tube and dispose of the product, replacing it with a single packed sterile version. If customers or users have any issues with the above recommendation, please send the affected packs back to Mölnlycke for a full refund. This action has been closed-out on 15/08/2016.


  • Modelo / Serial
    Waratah Private General Packs and Waratah Private Knee/Shoulder Arthro Pack(Surgical procedure packs)Waratah Private General PackCatalogue number (SKU) : 97035035-05Batch numbers: 15030983, 15038366, 15077945, 15100388Waratah Private Knee/Shoulder Arthro PackCatalogue number (SKU): 97067575-00Batch number: 15035436ARTG Number: 133565
  • Manufacturer