Events

Rappel de Devon Light Glove

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Covidien 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-2015-RN-00364-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-04-24
  • 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-2015-RN-00364-1
  • 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
    Covidien received reports that the light glove may contain splits or holes or be torn. should the user be unaware that the light glove is torn or split, a mode of transfer of microorganisms from the light handle into the patient wound is possible in the event the clinician touches the handle and then the sterile field. no adverse events have been reported.
  • Action
    Covidien is requesting the customers to immediately quarantine and discontinue use of the affected devices. Replacement product is not available at this time and Covidien will be issuing credit for the returned, unused and unexpired device(s). This action has been closed-out on 08/08/2016.

Device

Devon Light Glove
  • Modèle / numéro de série
    Devon Light GloveItem Number and Item Description 571711 NS-3600-B LITE GLOVE31140208 3611 LITE GLOVE31140216 3613 LITEGLOVE CS19231140257 3612 THEATRE LITE GLOVELot numbers beginning with 508xxxx or lowerManufactured: March 2012 through March 2015ARTG number: 186761
  • Manufacturer
    Covidien Pty Ltd

Manufacturer

Covidien Pty Ltd
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DHTGA