Events

Rappel de FAKWP (Fineline 6100258) and FAKSITE (Fineline 5820595) First Aid Kits

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

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-01234-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-11-27
  • 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-2014-RN-01234-1
  • 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
    Scott safety has been advised by the supplier, pacsource, of the ‘10 ml normal saline for irrigation’ with batch number 1t2324002 included in the kits may not be sterile after failing the test for sterility undertaken by the tga.
  • Action
    Scott Safety is recalling all affected First Aid Kits and requesting that these kits should be returned to them immediately. Scott Safety will inspect and replace ‘10 ml Normal Saline for Irrigation’ with alternate component that has already been secured. All new stock will be clearly marked with a QC sticker next to the barcode. This action has been closed-out on 18/03/2016.

Device

FAKWP (Fineline 6100258) and FAKSITE (Fineline 5820595) First Aid Kits
  • Modèle / numéro de série
    FAKWP (Fineline 6100258) and FAKSITE (Fineline 5820595) First Aid Kits All lot NumbersARTG Number: 170275
  • Manufacturer
    Scott Health and Safety

Manufacturer

Scott Health and Safety
  • Source
    DHTGA