Events

Rappel de Macopharma blood bags

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par MacoPharma 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-00994-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-09-16
  • 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-00994-1
  • 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
    Side slits and hanging holes have been reported missing on the final red cell pack of some bottom and top (bat) systems.The slits cut into the cv1014 pack are used to store the crossmatch line ‘pig-tails’. the hanging loop is used during the inversion of the pack to run additive into the concentrate red cells. this recall action was undertaken prior to consultation with the tga.
  • Action
    Macopharma is advising users that systems that are found to be absent of side slits and hanging loops should not be used, and that pack traceability is reported to to Macopharma for packs that cannot be returned. This action has been closed-out on 16/09/2016.

Device

Macopharma blood bags
  • Modèle / numéro de série
    Macopharma blood bagsProduct Code: LQT6283LBMultiple batches affectedARTG Number: 142856
  • Manufacturer
    MacoPharma Australia Pty Ltd

Manufacturer

MacoPharma Australia Pty Ltd
  • Société-mère du fabricant (2017)
    Macopharma
  • Source
    DHTGA