Events

Rappel de Compounded Medications within CADD Medication Non-flow stop Cassette Reservoirs

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Baxter Healthcare 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-01392-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-11-06
  • 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-01392-1
  • 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
    Baxter has been made aware of a recall initiated by smiths medical australasia of certain lots of 50 and 100ml cadd medication cassette reservoirs (non-flow stop) as they may have been manufactured with an incorrect pressure plate. baxter has identified some of the affected batches have been used to prepare compounded medications supplied to customers.
  • Action
    Baxter Healthcare is advising users to inspect stock and quarantine affected units. Baxter are re-issuing required cassettes, if required.

Device

Compounded Medications within CADD Medication Non-flow stop Cassette Reservoirs
  • Modèle / numéro de série
    Compounded Medications within CADD Medication Non-flow stop Cassette Reservoirs
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd