Events

Rappel de Scalpel in Lifemed Procedure Packs

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Bard 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-2018-RN-00267-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-04-20
  • 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-2018-RN-00267-1
  • 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
    Product complaints received by bard australia reported that the safety sheath covering the scalpel blade (component number in1951) was found in a very low number of lifemed procedure packs as being not engaged, resulting in an exposed blade that could inadvertently lead to a cut during manual handling by health care professionals, especially in circumstances where they are unaware of this anomaly whilst opening the pack.This issue does not impact the sterility of the packs.
  • Action
    Users are being made aware of this issue and asked to take extra care when opening the procedure packs. Affected units may be returned at the discretion of the customer on a case by case basis.

Device

Scalpel in Lifemed Procedure Packs
  • Modèle / numéro de série
    Scalpel in Lifemed Procedure PacksComponent: IN1951Multiple Product Codes and Lot NumbersARTG Numbers: 180554 Bard Australia - Surgical procedure kit, general- purpose, single-use, non-medicated;180555 Bard Australia - Angiographic kit;189114 Bard Australia - Lifemed Angiography Pack with Guidewire - Angiographic kit; and193043 Bard Australia - Surgical procedure kit, general-purpose, single-use, non-medicated
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd