Events

Rappel de Central Venous Catheter and Pressure Monitoring SetsSingle Lumen Central Venous Catheter Sets & Trays Femoral Artery Pressure Monitoring Catheter Sets & Trays Radial Artery Pressure Monitoring Catheter Sets & Trays

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par William A Cook Australia 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-00052-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2016-01-14
  • 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-00052-1
  • 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
    Certain central venous catheters and pressure monitoring sets are being recalled due to an issue being identified with a manufacturing process that could result in the potential for catheter tip fracture and/or separation. potential adverse events that may occur as a result of catheter tip fracture and or separation may include loss of device function, medical intervention to retrieve a separated segment, or complications resulting from a separated tip occluding blood flow to end organs. there have been no reports of illness or injury associated with this issue.
  • Action
    The sponsor is advising users to inspect stock and quarantine the affected units prior to their return to the sponsor.

Device

Central Venous Catheter and Pressure Monitoring SetsSingle Lumen Central Venous Catheter Sets & T...
  • Modèle / numéro de série
    Central Venous Catheter and Pressure Monitoring SetsSingle Lumen Central Venous Catheter Sets & TraysFemoral Artery Pressure Monitoring Catheter Sets & TraysRadial Artery Pressure Monitoring Catheter Sets & TraysReference Part Numbers (RPN): C-NPMS-501J-15, C-PMS-301-FA, C-PMS-301J-FA, C-PMS-301J-PED, C-PMS-301-RA, C-PMS-400-RA, C-PMS-401-FA and C-PMS-401J-FAMultiple Lot Numbers affectedARTG Numbers: 154878 and 156190
  • Manufacturer
    William A Cook Australia Pty Ltd

Manufacturer

William A Cook Australia Pty Ltd