Events

Rappel de Blood Pressure Monitoring Kits with Transpac IV Transducers

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-2016-RN-01335-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-10-19
  • 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-01335-1
  • 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
    It has been identified that there is a potential for leaks with certain monitoring kits that contain the transpac iv transducers. a small number of these devices may have the potential to leak or introduce small amounts of air into the line. in a worst case, there is potential patient harm due to air embolism or contamination. icu medical, inc. has not received any reports of adverse events associated with this issue.
  • Action
    ICU Medical is advising customers to arrange for their stock to be recovered and replacement stock, or a credit note to be issued. This action has been closed-out on 24/05/2017.

Device

Blood Pressure Monitoring Kits with Transpac IV Transducers
  • Modèle / numéro de série
    Blood Pressure Monitoring Kits with Transpac IV TransducersKit - Royal Women Hospital QLD, Special Care Nursery (Item: 011-0J069-01, Lot: 3253136)Kit - Neonatal/Childrens Australia (Item: 011-46103-16, Lot: 3263780)Safeset Transpac IV (Item: 011-46103-25, Lot: 3207778)Transpac IV (Item: 011-46104-49, Lot: 3242280)Single Line Monitoring Kit w/Transpac IV (Item: 011-46104-52, Lot: 3253165)Single Line Transpac IV Monitoring Kit (Item: 011-46107-16, Lot: 3235355)ARTG Number: 195624
  • Manufacturer
    ICU Medical Australia Pty Ltd

Manufacturer

ICU Medical Australia Pty Ltd
  • Source
    DHTGA