Events

Rappel de Cook Pereyra-Raz Ligature Carrier, Stamey Needle and Clarke-Reich Laparoscopic Knot PusherPereyra-Raz Ligature Carrier

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par William A Cook Australia 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-00539-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-05-08
  • 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-2017-RN-00539-1
  • 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 reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection and sterilisation of these products. preliminary investigation indicates that validation data related to the reprocessing of these devices do not meet the current guidance.There have been no reports of adverse reactions related to inadequate cleaning, disinfection, or sterilisation associated with these devices.
  • Action
    Users are requested to: 1. Review the list provided in the customer letter and examine inventory immediately to identify; and quarantine any affected products. 2. Complete and return the Acknowledgement and Receipt form provided as soon as possible. Users are further advised that supply of these products will be discontinued in Australia.

Device

Cook Pereyra-Raz Ligature Carrier, Stamey Needle and Clarke-Reich Laparoscopic Knot PusherPereyra...
  • Modèle / numéro de série
    Cook Pereyra-Raz Ligature Carrier, Stamey Needle and Clarke-Reich Laparoscopic Knot PusherPereyra-Raz Ligature Carrier Catalogue Identifier: 090002All LotsStamey NeedleCatalogue Identifier: 095030, 095015 and 095000All LotsClarke-Reich Laparoscopic Knot PusherCatalogue Identifier: J-CRKP-042900All LotsARTG Numbers: 212233 and 166926
  • Manufacturer
    William A Cook Australia Pty Ltd

Manufacturer

William A Cook Australia Pty Ltd