Events

Rappel de Various Sage Oral Care Products

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-2017-RN-01172-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-09-11
  • 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-2017-RN-01172-1
  • 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 australia has been advised by the manufacturer sage products llc that there is the potential for cross-contamination of specific oral care solutions manufactured by a third party supplier on equipment shared with non-pharmaceutical products. the affects all oral care products containing solutions manufactured by the third party supplier. the affected products were distributed between july 2015 and august 2017.
  • Action
    1. Discontinue use and/or further distribution of the affected lots. 2. Immediately quarantine any affected stock and complete the supplied acknowledgement form and email to austcs@teleflex.com 3. Destroy or dispose of affected product and provide records to Teleflex on the supplied acknowledgment form. 4. Complete the supplied recall acknowledgement form and return it to Teleflex. This form must be completed even if you no longer have affected product.

Device

Various Sage Oral Care Products
  • Modèle / numéro de série
    Various Sage Oral Care ProductsMultiple Product Codes and Lot NumbersARTG Numbers: 128439 and 135840
  • Manufacturer
    Teleflex Medical Australia Pty Ltd

Manufacturer

Teleflex Medical Australia Pty Ltd