Events

Rappel de AQUAPAK BRITISH and INTL 340 SW, 340 ML W/040B Humidifier Adaptors

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Teleflex 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-2015-RN-00138-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-03-03
  • 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-2015-RN-00138-1
  • 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
    Teleflex medical is recalling the products listed due to a possibility that the packages may contain foreign material, (predominantly synthetically derived pvc). this foreign matter has only been found in the package and not in the gas flow path of the humidifier product. if the foreign matter particles migrate into the sterile water reservoir, or enter the connecting tubing between the reservoir and the patient, the particle could potentially enter the patient airway at very high gas flows and could cause the hazard of mild lung discomfort, which is usually temporary and reversible.
  • Action
    A Teleflex representative will contact hospitals and medical centres to arrange for the affected devices to be inspected. Any units with foreign material will be recalled. If there is no visible foreign matter the product is safe to use. Unaffected batches are not expected to be available until May 2015. This action has been closed-out on 31/05/2016.

Device

AQUAPAK BRITISH and INTL 340 SW, 340 ML W/040B Humidifier Adaptors
  • Modèle / numéro de série
    AQUAPAK BRITISH and INTL 340 SW, 340 ML W/040B Humidifier AdaptorsCatalogue number: 400340 Batch Numbers: 149137, 307137, 362137, 385137Catalogue number: 003-40B Batch Numbers: 312137, 394137, 396137, 429137Catalogue Number: 400360 Batch Number: 91136ARTG Number: 215829
  • Manufacturer
    Teleflex Medical Australia Pty Ltd

Manufacturer

Teleflex Medical Australia Pty Ltd