Events

Rappel de Thoracentesis/paracentesis kit,Illinois needle aspiration,Jamshidi needle bone marrow

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par CareFusion Australia 316 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-2017-RN-00350-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-03-10
  • 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-2017-RN-00350-1
  • 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 has received six reports where an open seal of the immediate packaging of devices was identified by customers. this open seal has the potential to compromise the sterility of the device(s). to date, no reports have been received in australia.The packaging for the affected product codes were found to have an opening in the seal which maintains the sterility of the device. the issue of the packaging failure is visually obvious.
  • Action
    Customers are advised to discontinue use of the identified codes for the affected lot numbers. Contact BD to return and if required arrange a replacement or credit.

Device

Thoracentesis/paracentesis kit,Illinois needle aspiration,Jamshidi needle bone marrow
  • Modèle / numéro de série
    Thoracentesis/paracentesis kit,Illinois needle aspiration,Jamshidi needle bone marrow Thoracentesis/paracentesis kit 10/CS - TPK1001 Lot No. (LN): 0000851185, 0000840336, 0000842215, 0000837811Illinois (TJ) needle aspiration - TIN3015, TIN3018LN: 0000841213, 0000848061, 0000841215, 0000841212, 0000852078Jamshidi (TJ) needle bone marrow - TJM4011, TJC6011, TJC3513, TJC4011 LN: 0000852932, 0000843076, 0000853878, 0000841124, 0000851431, 0000850937 ARTG: 120894, 120890, 120892
  • Manufacturer
    CareFusion Australia 316 Pty Ltd

Manufacturer

CareFusion Australia 316 Pty Ltd