Events

Rappel de Transpac Monitoring Kits Arterial Safeset Transpac IT w/3 ml Reservoir and Single CSP, With Velcro Arm Strap, Patient Mount; Arterial Transpac IT Monitoring Kit w/Safeset Reservoir, 03 ml Flush Device and 2 CSP

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par ICU Medical 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-2014-RN-00877-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-08-08
  • 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-00877-1
  • 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
    Icu medical has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak. a leaking luer may have the potential effect of blood leakage or air embolism which may be life threatening or cause permanent severe injury or illness to the patient. there have been no reports of patient injury due to this problem.
  • Action
    ICU Medical Australia Pty Ltd is requesting their customers to inspect their stocks and quarantine all units from the affected lots. This action has been closed-out on 03/06/2016.

Device

Transpac Monitoring Kits Arterial Safeset Transpac IT w/3 ml Reservoir and Single CSP, With Velcr...
  • Modèle / numéro de série
    Transpac Monitoring KitsArterial Safeset Transpac IT w/3 ml Reservoir and Single CSP, With Velcro Arm Strap, Patient Mount Item Number: 011-46104-42Lot Numbers: 2841944, 2841945, 2859326, 2865873 & 2869445Arterial Transpac IT Monitoring Kit w/Safeset Reservoir, 03 ml Flush Device and 2 CSP Item Number: 011-46106-72Lot Numbers: 2841690, 2841691 & 2859331ARTG Number: 206780
  • Classification du dispositif
    Cardiovascular Devices
  • Manufacturer
    ICU Medical Australia Pty Ltd

Manufacturer

ICU Medical Australia Pty Ltd
  • Source
    DHTGA