Events

Rappel de Fischer Cone Biopsy ExcisorSize medium (5/box)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Life Healthcare 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-2018-RN-00308-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2018-04-13
  • 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-2018-RN-00308-1
  • 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
    Finished product in lot number 212074 was identified to have been incorrectly labelled. the label incorrectly indicates the part number used for large size instead of the medium size excisor. this discrepancy does not meet the product release specifications.
  • Action
    Customers are asked to isolate these items and place affected units in the supplied plastic bag for collection by LifeHealthcare. Replacement stock will be provided in due course. A copy of the Reply Form attached to the Customer Letter should be returned by fax or email and also be enclosed with the stock to be returned.

Device

Fischer Cone Biopsy ExcisorSize medium (5/box)
  • Modèle / numéro de série
    Fischer Cone Biopsy ExcisorSize medium (5/box)Part Number: AP-900-151 Lot Number: 212074ARTG Number: 215626(Life Healthcare - Electrode, electrosurgical, active, foot-controlled, single use)
  • Manufacturer
    Life Healthcare Pty Ltd

Manufacturer

Life Healthcare Pty Ltd