Events

Rappel de Aerowound Combine Dressing ACD2040S, size 20cm x 40cm

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Aero Healthcare.

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-00283-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-02-27
  • 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-00283-1
  • 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
    The aerowound combine dressing is comprised of an absorbent pad enclosed in a polyester/viscose over bag. each sterile dressing is sealed in an individual pouch. it was discovered that one of the pouch edges has a weak sealing strength which could compromise the sterility of the device.
  • Action
    Aero Healthcare is advising customers to quarantine all affected stock within their control. Distributors are advised to forward the recall notice to retailers to whom they have sold affected products and to accept the affected stock returned to them. Distributors are further requested to contact Aero Healthcare to organise their return.

Device

Aerowound Combine Dressing ACD2040S, size 20cm x 40cm
  • Modèle / numéro de série
    Aerowound Combine Dressing ACD2040S, size 20cm x 40cmBatch Number: 17110Expiry Date: 31 August 2021ARTG Number: 159437
  • Manufacturer
    Aero Healthcare

Manufacturer

Aero Healthcare