Events

Rappel de Renasys Transparent Film and Renasys Gauze Dressing Kits (used to dress, protect and seal wounds undergoing Negative Pressure Wound Therapy (NPWT))

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Smith & Nephew 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-2016-RN-01065-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-08-10
  • 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-2016-RN-01065-1
  • 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
    Smith & nephew have identified seal integrity failures on the folded sterile renasys transparent film pouches during transit testing. all the seal integrity failures identified during the testing occurred at the point where the sterile renasys transparent film pouches were folded during the packaging process.The loss of sterility has the potential to contribute to a local infection. to date, smith & nephew is not aware of any complaints reported in relation to this issue that has led to a local infection.
  • Action
    Smith & Nephew are advising users to inspect stock and quarantine all affected units. In the event that a Transparent Film is required for NPWT therapy, the responsible Health Care Professional should be consulted to determine an alternative Transparent Film or alternative treatment. Affected stock can be returned and replaced with unaffected product.

Device

Renasys Transparent Film and Renasys Gauze Dressing Kits (used to dress, protect and seal wounds ...
  • Modèle / numéro de série
    Renasys Transparent Film and Renasys Gauze Dressing Kits (used to dress, protect and seal wounds undergoing Negative Pressure Wound Therapy (NPWT))Part Numbers: 66800394, 66800932, 66800933, 66800934, 66800935, 66800936, 66801255, 66801256, 66801257, 66801258Multiple Products and Lot Numbers affectedARTG Number: 149671
  • Manufacturer
    Smith & Nephew Pty Ltd

Manufacturer

Smith & Nephew Pty Ltd