Events

Rappel de Multiple ProcedurePak Trays with Ecolab-Microtek Medical Basin Liners

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Molnlycke Health Care 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-2014-RN-01082-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-10-08
  • 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-2014-RN-01082-1
  • 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
    Mölnlycke health care has received a recall notification from ecolab-microtek medical regarding basin liners which are contained within procedurepak products. the supplier has identified that very low number of basin liners have small holes or cracks which if present may compromise sterility.
  • Action
    Molnlycke Healthcare is requesting their customers to isolate any product from the affected batches. Mölnlycke Health Care will arrange for the collection and replacement of the product. This action has been closed-out on 06/06/2016. This action has been closed-out on 06/06/2016.

Device

Multiple ProcedurePak Trays with Ecolab-Microtek Medical Basin Liners
  • Modèle / numéro de série
    Multiple ProcedurePak Trays with Ecolab-Microtek Medical Basin LinersProcedurePak Trays:Maxillo Facial Pack Rev4, Cairns Base Maxillo Facial Pack Rev4, Cairns Base Limb Rev6SKU: 97006791-05, 97006791-07, 97008210-07Batch ID: 12073320, 12080223, 12168637Basin Liner Product Codes: 2302362-00 & 2309247-00ARTG Numbers: 213220 & 133564
  • Manufacturer
    Molnlycke Health Care Pty Ltd

Manufacturer

Molnlycke Health Care Pty Ltd