Events

Rappel 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)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Teleflex Medical Australia Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2016-RN-01128-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-09-05
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01128-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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...
  • Modèle / numéro de série
    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