Events

Rappel de Twin-Pass dual access catheters

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Pyramed 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-2016-RN-01234-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-09-21
  • 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-2016-RN-01234-1
  • 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
    An investigation of twin-pass units has concluded there is a potential for excess manufacturing material to remain at the tip of the catheter or inside the distal part of the rapid exchange lumen of twin-pass dual access catheters. it is possible that the excess material may separate from the catheter during a procedure which poses a potential risk of an embolism to the patient. there have been no reports of injuries associated with this issue.This action has been undertaken prior to consultation with the therapeutic goods administration (tga).
  • Action
    Pyramed has advised users to quarantine and return the affected devices. This action has been closed-out on 11/11/2016.

Device

Twin-Pass dual access catheters
  • Modèle / numéro de série
    Twin-Pass dual access cathetersModel Number: 5200Multiple lot numbers affectedSupplied through the Special Access Scheme (SAS)
  • Manufacturer
    Pyramed Pty Ltd

Manufacturer

Pyramed Pty Ltd