Events

Rappel de LipiFlow System Activator (used as part of the LipiFlow Thermal Pulsation System)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Emergo Asia Pacific Pty Ltd T/a Emergo Australia.

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-00319-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2017-03-07
  • 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-00319-1
  • 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
    There is a labelling issue with specific lots of the lipiflow system activator. the activator package label, box label, package insert and the lipiflow system instructions for use (ifu) specify 10°c to 40°c for the activator storage temperature. this specification was with the intent that the activator would be stored in a temperature-controlled room environment (with heat and air conditioning) with allowance for occasional fluctuations between 10°c and 40°c.Upon review, it has been determined that the labelled storage temperature should be consistent with the temperature conditions tested for the entire duration of the product shelf-life. accordingly, the storage temperature on the activator package and box labels has been revised to specify, “store at controlled room temperature.” the revised package insert and the lipiflow system ifu specify: “store the activator at controlled room temperature (20°c to 25°c) with short-term (< 72 hours) excursions permitted between 5°c and 38°c.”.
  • Action
    Emergo is requesting customers to read the enclosed "Summary of Important Labelling Changes for the LipiFlow System" and discontinue use of stock that are not in temperature-controlled environments (without heat and air conditioning). Customers are further requested to contact their local distributor to organise for replacement stock. This action has been closed-out on 23/06/2017.

Device

LipiFlow System Activator (used as part of the LipiFlow Thermal Pulsation System)
  • Modèle / numéro de série
    LipiFlow System Activator (used as part of the LipiFlow Thermal Pulsation System)Model Number: LFD-1000All Lots distributed between 1 Jan 2014 to 3 Feb 2017Expiry Date: Jul 2017 to Feb 2021ARTG Number: 189438
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia