Events

Rappel de Rocket IPC Drainage Bottle (A collection device used to collect fluid or air from the pleural cavity)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Rocket Medical 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-01151-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-11-14
  • 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-2014-RN-01151-1
  • 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
    Rocket medical is notifying customers the blue connector tube may not open once the white clip is removed due to a manufacturing irregularity. if this occurs the vacuum contained in the bottle will not be applied to the patient, therefore no fluid can be drained. if left, the connector tube will still open with a delay of up to 5-6 minutes.
  • Action
    Rocket Medical is advising customers to open the tube by gently manipulating the tube forwards and backwards when the white clip has been opened. This action has been closed-out on 01/03/2016.

Device

Rocket IPC Drainage Bottle (A collection device used to collect fluid or air from the pleural cav...
  • Modèle / numéro de série
    Rocket IPC Drainage Bottle (A collection device used to collect fluid or air from the pleural cavity)Product Codes: R54400, R54400-00-PP, R54410, R51400, R51400-00-PP, R51410ARTG Number: 145658
  • Manufacturer
    Rocket Medical Pty Ltd

Manufacturer

Rocket Medical Pty Ltd