Rappel de Ultrasound Probe Cover (Telescopic folded with gel); and All Products labelled Meditech and Manufactured by: Yafho Bio-Technology Co Ltd; and/or Linmed Medical Co Ltd.

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Meditech Systems Asia Pacific 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-00631-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2017-05-12
  • Pays de l'événement
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
  • 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
    Meditech systems asia pacific has become aware that the product ultrasound probe cover (telescopic folded with gel) may be contaminated with burkholderia cenocepacia. whilst no other batches or pack sizes of this product have been supplied by meditech, users are further advised that all products labelled meditech and manufactured by: yafho bio-technology co ltd; and/or linmed medical co ltd.Are also affected by this recall.
  • Action
    All product labelled Meditech and Manufactured by Yafho Bio-Technology Co Ltd and/or Linmed Medical Co Ltd, including all stock of UltraSound Probe Cover (Telescopic folded with gel), is being quarantined immediately and Recalled from the Market. For further information please see https://www.tga.gov.au/alert/meditech-ultrasound-gel .

Device

  • Modèle / numéro de série
    Ultrasound Probe Cover (Telescopic folded with gel); andAll Products labelled Meditech and Manufactured by: Yafho Bio-Technology Co Ltd; and/or Linmed Medical Co Ltd.Part Number/ Order Code: 88654012Lot Number: 201701ARTG Number: 278197
  • Manufacturer

Manufacturer