Events

Rappel de LeMaitre Single Lumen Embolectomy Catheter 3F, 80 cm

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-2015-RN-01089-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-11-09
  • 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-01089-1
  • 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
    Lemaitre embolectomy catheters are indicated for the removal of arterial emboli and thrombi. a small number of these products from the affected lot may have a compromised sterile barrier due to a packaging tube defect in the form of a pinhole at the sealed end of the packaging tube. the current ifu does not require inspection of the packaging prior to use and loss of product sterility could not be visually identified. the issue occurred due to fluctuations in the power sources for the sealing machine during the packaging tube manufacturing process.Loss of product sterility could lead to cross-contamination and infection.No complaints have been received relating to this issue.
  • Action
    Users are asked to inspect their stock and quarantine all affected units prior to their return to Emergo as per the instructions in the Customer Letter. This action has been closed-out on 18/08/2016.

Device

LeMaitre Single Lumen Embolectomy Catheter 3F, 80 cm

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia