Events

Rappel de TOPPER Xtra Absorbent Dressing Pads, Sterile

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par KCI 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-2014-RN-00893-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-08-21
  • 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-2014-RN-00893-1
  • 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 manufacturer, systagenix has become aware that the sterility of some product may be compromised due to small holes in the bottom layer of the primary pouch; its subsequent use may therefore pose a potential risk of localised infection.
  • Action
    Users are advised to discontinue use of affected stock and monitor any patients who are using, or have recently used, any of the affected products for signs of localised infection, including heat, pain, redness or swelling around the wound or increased wound drainage. If symptoms are presented then the clinician should treat appropriately. This action has been closed-out on 1/06/2016.

Device

TOPPER Xtra Absorbent Dressing Pads, Sterile
  • Modèle / numéro de série
    TOPPER Xtra Absorbent Dressing Pads, Sterile Product codes: P55263 and P55264 – all pack sizesAll lots affectedARTG number: 168750
  • Manufacturer
    KCI Medical Australia Pty Ltd

Manufacturer

KCI Medical Australia Pty Ltd