Events

Rappel de AbbVie Percutaneous Endoscopic Gastronomy and Jejunal tubing kits (AbbVie PEG and AbbVie J)(used for administration of medication Duodopa (Levodopa Carbidopa) Intestinal Gel)AbbVie PEG 15 R

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Abbvie 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-00619-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2017-05-17
  • 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-00619-1
  • 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
    Abbvie has identified the potential for missing components and / or duplicate components in the abbvie peg 15 r and abbvie j intestinal tube 9 fr for peg 15 fr kits. the reported events of missing components have not been associated with any reports to abbvie of related serious injury and it is unlikely for the missing components to pose any significant safety risk.
  • Action
    AbbVie is advising users to inspect the kits using the product’s Instructions for Use, product description section to ensure all components are present before proceeding with implantation. Any missing components are to be reported to AbbVie, including details of the device lot number, and the kit returned to AbbVie. AbbVie will provide replacement kits if there are missing components.

Device

AbbVie Percutaneous Endoscopic Gastronomy and Jejunal tubing kits (AbbVie PEG and AbbVie J)(used ...
  • Modèle / numéro de série
    AbbVie Percutaneous Endoscopic Gastronomy and Jejunal tubing kits (AbbVie PEG and AbbVie J)(used for administration of medication Duodopa (Levodopa Carbidopa) Intestinal Gel)AbbVie PEG 15 R Product Code: 62941-001AbbVie J Intestinal Tube 9 FR for PEG 15 FR Product Code: 62943-001All lots may be affected.ARTG Numbers: 223443 and 223444
  • Manufacturer
    Abbvie Pty Ltd

Manufacturer

Abbvie Pty Ltd