Events

Rappel de 9025RHTR ABG Sampling Kit

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par CareFusion Australia 316 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-01226-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-09-26
  • 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-01226-1
  • 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
    Carefusion have been advised of an issue with a specific lot of 9025rhtr abg sampling kits. these kits should contain a sub-assembly comprised of a 25 gauge needle, with 1ml syringe, and 3.12 international units (iu) of heparin. an error in manufacturing of one lot of the 9025rhtr abg kit(s) has been identified as incorrectly containing a sub-assembly which includes a larger needle (23 gauge needle), larger syringe (3ml), and larger amount of heparin (113iu), than what is intended for the kit.To date, no reports relating to this issue have been receivedin australia, and carefusion is not aware of any report of injury attributed to this defect in australia.
  • Action
    1. Discontinue use of and segregate the above identified Lot Numbers of Catalogue Number 9025RHTR ABG Sampling Kit with lot number 0001047501. 2. CareFusion is requesting any impacted inventory be set aside for collection. 3. Users are to Complete the supplied Customer Acknowledgement Form to confirm receipt of this notification and return to CareFusion as directed. 4. CareFusion will then arrange for the pick-up of your affected stock and issue a credit.

Device

9025RHTR ABG Sampling Kit

Manufacturer

CareFusion Australia 316 Pty Ltd