Events

Rappel de CADD Medication Cassette Reservoir, 50ml

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Smiths Medical Australasia 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-00081-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-01-30
  • 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-00081-1
  • 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
    Smiths medical has received a small number of complaints of leakage associated with the above-referenced cassettes. a small amount of leaking has been found to occur at the welding of the tube to the internal reservoir bag on some cassettes. if the leakage is noticed during cassette filling, it could result in a delay of therapy while an alternative cassette is obtained. if the leakage is noticed during fluid delivery with the patient, it could result in an interruption in therapy while the cassette is replaced.
  • Action
    End users are requested to inspect their inventory and quarantine the affected Cassettes. A customer service representative will arrange for exchange of any unused affected Cassettes for credit or replacement. This action has been closed-out on 17/08/2016.

Device

CADD Medication Cassette Reservoir, 50ml
  • Modèle / numéro de série
    CADD Medication Cassette Reservoir, 50ml Order Code: 21-7001-24Batch Numbers: 14X297 and 14X323Order Code: 21-7301-24Batch Numbers: 14X324ARTG Number: 145297
  • Manufacturer
    Smiths Medical Australasia Pty Ltd

Manufacturer

Smiths Medical Australasia Pty Ltd