Events

Rappel de American Surgical Company (ASC ) Neuro Sponges Products affected: Americot Blue sponges, Cotton Balls, Ray-Cot sponges, Delicot sponges, Uniqcot sponges and Telfa sponges

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Life Healthcare 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-00433-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-04-14
  • 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-00433-1
  • 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
    A failure in the sterile peel pouch has been discovered during a quality control inspection by the manufacturer, asc. this failure may result in a small tear in the pouch of the device leading to a potential compromised sterile barrier. a leak in the sterile barrier may allow contamination of the device increasing the risk of infection. a comprehensive investigation has identified an occurrence rate of less than 0.01% for the affected lots.
  • Action
    LifeHealthcare is advising users to inspect stock and quarantine any remaining product for return. This action has been closed-out on 30/01/2017.

Device

American Surgical Company (ASC ) Neuro Sponges Products affected: Americot Blue sponges, Cotton B...
  • Modèle / numéro de série
    American Surgical Company (ASC ) Neuro Sponges Products affected: Americot Blue sponges, Cotton Balls, Ray-Cot sponges, Delicot sponges, Uniqcot sponges and Telfa spongesMultiple item and lot numbers affected (see attached)ARTG Numbers: 265712, 265713 and 146103
  • Manufacturer
    Life Healthcare Pty Ltd

Manufacturer

Life Healthcare Pty Ltd