Events

Rappel de CAPD Solution Transfer Set with Locking Connector, Minicap Extended Life PD Transfer Set with Twist Clamp, Minicap Extended Life PD Transfer Set with Twist Clamp (Extra Short and Extra Long)

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-2013-RN-00536-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-06-06
  • 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-2013-RN-00536-1
  • 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 is providing additional information regarding correct device use and additional warnings to end users. the improper use of peritoneal dialysis (pd) transfer sets could result in contamination leading to infection or peritonitis. there is also the potential of thyroid dysfunction following iodine exposure in children and infants. the current ifu does not list this as a warning.
  • Action
    Baxter is providing additional information regarding correct device use and additional warnings to end users. This action has been closed-out on 01/02/2016.

Device

CAPD Solution Transfer Set with Locking Connector, Minicap Extended Life PD Transfer Set with Twi...
  • Modèle / numéro de série
    CAPD Solution Transfer Set with Locking Connector, Minicap Extended Life PD Transfer Set with Twist Clamp, Minicap Extended Life PD Transfer Set with Twist Clamp (Extra Short and Extra Long)CAPD Solution Transfer Set with Locking ConnectorProduct code: 5C4160Minicap Extended Life PD Transfer Set with Twist ClampProduct code: 5C4482, R5C4482Extra Short product code: 5C4483, R5C4483Extra Long product code: R5C4484ARTG Number: 167416
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd