Events

Rappel de Self-Righting Luer Slip Tip Cap, Yellow in the DISCPAC packaging

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-2015-RN-00113-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2015-03-05
  • 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-00113-1
  • 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 healthcare identified that the affected products (self-righting luer slip and luer lock tip caps ) were manufactured and shipped with inaccurate single and case labels, missing the latex symbol. the heat shrink tape used on the discpac package is the only product component that contains latex. the instructions for use (ifu) correctly identifies the content of latex. unintended or accidental exposure to latex has the potential to elicit a hypersensitivity reaction, especially in sensitised individuals. symptoms may range from skin irritation to anaphylaxis. baxter has not received any reports of adverse events associated with this issue.
  • Action
    Baxter is alerting its customers of this labelling issue of missing latex symbol in an effort to prevent unintended exposure to latex. Baxter is updating the labelling of the affected products to include the latex symbol for future batches. This action has been closed-out on 02/03/2016.

Device

Self-Righting Luer Slip Tip Cap, Yellow in the DISCPAC packaging
  • Modèle / numéro de série
    Self-Righting Luer Slip Tip Cap, Yellow in the DISCPAC packagingProduct Code: H93866025All lot numbers with expiration date 10/2014 to 10/2017ARTG number: 217859
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd