Events

Rappel de MiniCap Extended Life PD Transfer Set with Twist Clamp (Peritoneal dialysis tubing set)

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-2014-RN-00536-2
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-05-13
  • 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-2014-RN-00536-2
  • 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 received complaints reporting connection issues between the pd transfer set catheter connector and an adapter with this lot number. connection issues between the pd transfer set catheter connector and an adapter may lead to leaks and contamination of the fluid pathway which may result in peritonitis.
  • Action
    Hospitals and distributors are asked to locate and return all the affected products at their facility. Health professionals are asked to ensure that home patients are notified of this recall and identify patients who are currently using the affected lot for replacing the unused transfer sets with unaffected stock. For more details, please see http://www.tga.gov.au/safety/alerts-device-minicap-extended-life-pd-140515.htm .This action has been closed-out on 29/01/2016.

Device

MiniCap Extended Life PD Transfer Set with Twist Clamp (Peritoneal dialysis tubing set)

Manufacturer

Baxter Healthcare Pty Ltd