Events

Rappel de Multigate Custom Procedure Packs containing Convatec’s Unomedical brand Suction Tube

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Multigate Medical Products 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-2015-RN-00601-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-07-02
  • 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-2015-RN-00601-1
  • 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 is conducting a recall (tga ref no: rc-2015-rn-00514-1) of various sized unomedical branded suction tubes. the tubes are being recalled as the connector on the tubes has a probability of cracking once it is applied to suction device ports.Multigate is issuing this notice to your hospital as you have received the above custom procedure packs (cpp) where you have specified the inclusion of the unomedical suction tube that is now subject to this recall.
  • Action
    Multigate requesting end users to stop using the affected CPP. Multigate will supply replacement sterile tubing as for all the affected stock. Once replacement tubing is received end users are required to replace the defective tube with the sterile replacement product.

Device

Multigate Custom Procedure Packs containing Convatec’s Unomedical brand Suction Tube

Manufacturer

Multigate Medical Products Pty Ltd