Events

Rappel de Frazier Suction instrument (used for precision suction in spinal or neurological surgeries)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par ConvaTec 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-00923-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-07-12
  • 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-00923-1
  • 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
    Convatec (australia) pty ltd is issuing an instruction for use (ifu) for their unomedical brand frazier suction instrument which currently is supplied without an ifu. this action is being taken in response to complaints from the users in relation to breaking of the instrument at the junction of the handle and the metal tubing when pressure is applied at the tip. if the issue were to occur, it would result in a loss of suction and loss of visibility in the surgical field. there have been no reports of injuries as a result of this issue.
  • Action
    The manufacturer has decided to issue an IFU to instruct the users on how to use the product appropriately to avoid any breakage of the instrument. ConvaTec is providing hospitals with the IFU along with the customer letter. This action has been closed-out on 07/02/2017.

Device

Frazier Suction instrument (used for precision suction in spinal or neurological surgeries)
  • Modèle / numéro de série
    Frazier Suction instrument (used for precision suction in spinal or neurological surgeries)Product Codes: 309.02.006, 309.02.008, 309.02.008L, 309.02.010, 309.02.010L, 309.02.012, 309.02.012LAll lots affectedARTG Number: 172620
  • Manufacturer
    ConvaTec Australia Pty Ltd

Manufacturer

ConvaTec Australia Pty Ltd