Events

Retiro De Equipo (Recall) de Sage Comfort impregnated cloth topical skin products(impregnated with barrier creams and/or antiseptic agents & are used to protect &/or clean areas of skin)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Teleflex Medical 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-01128-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-09-05
  • 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-01128-1
  • 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 recall was initiated due to product contamination of a few lots of comfort shield barrier cream cloths with the bacteria, burkholderia cepacia, that were manufactured on two production lines. although the contamination has not been identified in any other products, all products manufactured on the same production lines in the relevant period have also been recalled.Topical administration of a product with presence of microbial contamination may cause serious infections in immunocompromised persons and in hospitalised patients, as well as certain other patient groups.
  • Acción
    Teleflex Medical is advising users to inspect stock and quarantine any remaining units of the affected product. Stock can be returned to Teleflex or place of purchase for a credit, refund or replacement. For more details, please see https://www.tga.gov.au/alert/comfort-impregnated-cloth-topical-skin-products . This action has been closed-out on 28/06/2017.

Device

Sage Comfort impregnated cloth topical skin products(impregnated with barrier creams and/or antis...
  • Modelo / Serial
    Sage Comfort impregnated cloth topical skin products(impregnated with barrier creams and/or antiseptic agents & are used to protect &/or clean areas of skin)Catalogue Numbers: 7453, 7526, 7905, 7413, 7988, 9601, 9602Various batch numbers affected (see attached)ARTG Number: 227609
  • Manufacturer
    Teleflex Medical Australia Pty Ltd

Manufacturer

Teleflex Medical Australia Pty Ltd